management tool oracle® health sciences inform user user guide · assigning a oracle inform user...

Oracle® Health Sciences InForm UserManagement ToolUser Guide

Release 12.1F30102-01

Oracle Health Sciences InForm User Management Tool User Guide, Release 12.1

F30102-01

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Contents

Preface

Documentation accessibility ix

Related resources ix

Access to Oracle Support ix

Additional copyright information ix

1 Getting started

Main functions 1-1

Getting a new password 1-2

Changing the login password 1-2

Viewing audit trails 1-2

Logging out of the application 1-3

Getting Help 1-3

2 Regulatory requirements

Regulatory requirements for Oracle InForm User Management Tool 2-1

3 Workflow for giving users access to an Oracle InForm study

About the workflow for giving users access to an Oracle InForm study 3-1

STEP 1: Create the study user account 3-1

Single sign-on (SSO) study user accounts 3-2

Non-SSO study user accounts 3-3

STEP 2: Assign and confirm training 3-3

Oracle Health Sciences Learn (HS Learn) training 3-4

Alternate training resource (optional) 3-5

STEP 3: Ensure the study user is trained and approved 3-5

STEP 4: Add the study user to Oracle InForm 3-5

SSO users—Authorize the study user to access the Oracle InForm study 3-6

Non-SSO users—Mark users to upload to Oracle InForm 3-6

STEP 5: Lock the study in Oracle InForm User Management Tool for development 3-6

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STEP 6: Generate and upload the Oracle InForm study data 3-7

STEP 7: Make sure the Oracle InForm study is live 3-7

STEP 8: Send the study user the authorization email with the study URL details 3-7

SSO users—Send the authorization email 3-8

Non-SSO users—Send the Oracle InForm account details 3-9

4 Managing users

Oracle InForm and Oracle IRT users 4-1

Viewing the list of InForm or IRT users 4-1

Creating Oracle InForm or Oracle IRT users 4-2

Viewing and modifying user details 4-3

Viewing the sites a user is associated with 4-4

Associating a user with a site 4-4

Terminating users 4-5

Viewing terminated users 4-5

Unterminating (re-instating) users 4-6

Approving or rejecting users 4-6

Marking users for upload to Oracle InForm or Oracle IRT 4-7

Assigning Oracle Health Sciences Learn classes to a user 4-7

Marking users as trained 4-8

Sending user account details 4-8

Exporting users 4-9

Updating a user's name in email notifications 4-9

Updating assessment status 4-10

Assigning a preferred study locale to a user 4-10

Oracle InForm User Management Tool users 4-10

Viewing the list of Oracle InForm User Management Tool users 4-11

Creating Oracle InForm User Management Tool users 4-11

Viewing and modifying Oracle InForm User Management Tool user details 4-12

Activating Oracle InForm User Management Tool users 4-12

Terminating Oracle InForm User Management Tool users 4-12

Viewing terminated Oracle InForm User Management Tool users 4-13

Unterminating Oracle InForm User Management Tool users 4-13

Resetting the password for a Oracle InForm User Management Tool user 4-13

Resending Oracle InForm User Management Tool login details 4-13

Global users 4-14

Viewing the list of Global users 4-14

Creating Global users 4-14

Assigning a product to a Global user 4-15

Viewing and modifying global user details 4-16

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Terminating a Global user 4-16

Viewing the terminated user list 4-17

Unterminating Global users 4-17

5 Managing trials

Viewing the list of trials 5-1

Viewing and modifying trial details 5-1

Bulk copying 5-2

Selective copying 5-2

Archiving trials 5-3

Viewing archived trials 5-3

Exporting trial details 5-3

Exporting trials 5-4

Importing administrative data for a trial 5-4

Locking a trial for development 5-5

Generating Oracle InForm XML 5-5

Generating Oracle InForm XML for pre Go-Live production trials 5-5

Generating an Oracle InForm XML ZIP file for upload to Oracle InForm 5-6

6 Managing sites

Viewing the list of sites 6-1

Creating sites 6-2

Viewing and modifying site details 6-2

Changing a site mnemonic 6-3

Approving or rejecting sites 6-3

Marking sites as uploaded to Oracle InForm or Oracle IRT 6-4

Marking sites as not participating 6-4

Viewing not participating sites 6-4

Marking a not participating site as participating 6-5

Assigning or updating the study version 6-5

Exporting sites 6-6

Updating the assessment status for a site 6-6

Sending an assessment email to a site 6-6

Stopping the assessment process for a site 6-6

Assigning a preferred study locale to a site 6-7

7 Managing roles

Managing Oracle InForm roles 7-1

Viewing the list of Oracle InForm roles 7-1

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Creating Oracle InForm roles 7-1

Viewing and modifying Oracle InForm role details 7-2

Assigning an Oracle InForm role to a user 7-3

Assigning Oracle Health Sciences Learn classes to a role 7-3

Setting the display override option 7-3

Approving or rejecting Oracle InForm roles 7-4

Transferring Oracle InForm roles 7-4

Managing Oracle IRT roles 7-4

Viewing the list of Oracle IRT roles 7-5

Creating Oracle IRT roles 7-5

Approving or rejecting Oracle IRT roles 7-5

Managing Oracle InForm User Management Tool roles 7-6

Viewing the list of Oracle InForm User Management Tool roles 7-6

Creating Oracle InForm User Management Tool roles 7-6

Oracle InForm User Management Tool roles and rights 7-7

UMT Admin rights 7-7

Import/Export rights 7-8

User/Sponsor/Site details rights 7-9

Log file rights 7-9

Approval rights 7-10

InForm rights 7-10

Miscellaneous rights 7-10

Viewing and modifying Oracle InForm User Management Tool role details 7-10

Assigning a Oracle InForm User Management Tool role to a user 7-11

Deleting Oracle InForm User Management Tool roles 7-11

8 Managing groups

Viewing the list of groups 8-1

Creating groups 8-1

Importing group data from Oracle Central Designer with the Shell Report 8-2

Viewing and modifying user and group associations 8-2

Validating AutoQuery groups 8-3

Viewing and modifying group details 8-3

Approving or rejecting groups 8-3

9 Managing reports

Generating reports 9-1

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10

Managing assessment

Viewing the list of assessed users 10-1

Updating assessment status for an assessed user 10-1

Viewing assessment comment history 10-2

Adding, editing, and deleting assessment comments 10-2

11

Managing log files

Viewing the list of log files and transferred data 11-1

Archiving log files 11-1

Viewing archived log files 11-1

12

Oracle Health Sciences Learn (HS Learn) training

Assigning an Oracle Health Sciences Learn class to a trial 12-1

Managing training 12-1

13

Configuring settings

Configuring Oracle InForm settings 13-1

Configuring editable system configuration options for trials on the trial level 13-1

Configuring editable system configuration options for new and existing trials onthe sponsor company level 13-2

Configuring a custom review state 13-2

Exporting Oracle InForm configuration settings 13-3

Oracle InForm User Management Tool Settings 13-3

Configuring Oracle InForm User Management Tool settings 13-3

Configuring default trials, sites, and user settings 13-3

Exporting Oracle InForm User Management Tool configuration settings 13-4

Configuring assessment 13-5

Configuring assessment benchmark 13-5

14

Loading data into the Oracle InForm User Management Tool

About loading data into the Oracle InForm User Management Tool 14-1

Updating your Excel options 14-2

Using the MUL Template to add or change data 14-3

Download the template for a trial 14-3

Update the template for a trial 14-3

Upload the updated data to Oracle InForm User Management Tool 14-5

Creating a master template from the MUL Template 14-6

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Download a blank template 14-6

Add additional study locale languages to the MUL Template 14-6

Update the spreadsheet 14-7

Entering data in the MUL Template 14-8

Adding or updating user roles 14-9

Assigning rights and roles 14-10

Adding groups and assigning a group type 14-10

Assigning reporting groups to roles 14-11

Entering site data 14-11

Updating site data 14-12

Entering Sponsor and Site users 14-13

Updating Sponsor and Site users 14-14

Entering UAT users (Single sign-on trials only) 14-15

Entering signature groups 14-15

15

Managing SSO accounts—Oracle Health IAMS CustomerDelegated Administrator (CDA)

Resetting a user SSO password 15-1

Locking a user SSO account 15-2

Unlocking a user SSO account 15-2

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Preface

This preface contains the following sections:

• Documentation accessibility

• Related resources

• Access to Oracle Support

• Additional copyright information

Documentation accessibilityFor information about Oracle's commitment to accessibility, visit the OracleAccessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Related resourcesAll documentation and other supporting materials are available on the Oracle HelpCenter.

Access to Oracle SupportOracle customers that have purchased support have access to electronic supportthrough Support Cloud.

Contact our Oracle Customer Support Services team by logging requests in one of thefollowing locations:

• English interface of Oracle Health Sciences Customer Support Portal (https://hsgbu.custhelp.com/)

• Japanese interface of Oracle Health Sciences Customer Support Portal (https://hsgbu-jp.custhelp.com/)

You can also call our 24x7 help desk. For information, visit http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Additional copyright informationThis documentation may include references to materials, offerings, or products thatwere previously offered by Phase Forward Inc. Certain materials, offerings, services,or products may no longer be offered or provided. Oracle and its affiliates cannot beheld responsible for any such references should they appear in the text provided.

ix

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc

https://docs.oracle.com/en/industries/health-sciences/user-management-tool/index.html

https://docs.oracle.com/en/industries/health-sciences/user-management-tool/index.html

https://hsgbu.custhelp.com/


https://hsgbu-jp.custhelp.com/

https://hsgbu-jp.custhelp.com/

http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html


http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs

1Getting started

• Main functions

• Getting a new password

• Changing the login password

• Viewing audit trails

• Logging out of the application

• Getting Help

Main functions

Note:

Oracle InForm User Management Tool is supported with Internet Exploreronly.

The main functions of this application are:

• Delivers a robust, validated, secure, and intuitive user management environmentthat can be used across all Oracle InForm trials.

– Lets you import information to the Oracle InForm User Management Tool fromexternal source files such as Excel spreadsheet and DAT files.

– Facilitates global updates to Oracle user information.

• Provides easy-to-use interface and data exchange for the automated transfer ofinformation to the Oracle InForm trial, Automated Site Assessment (ASA) used forend-user infrastructure assessments, and Oracle Health Sciences Learn end-usercomputer-based training application.

• Provides Dual Control functionality, where two users are required to perform atransaction, such as creating and managing sites, and creating users andconfiguration related records.

• Provides an integrated training log for updating and reviewing the training status oftrial personnel.

• Provides a flexible environment for users to extract information from the OracleInForm User Management Tool in a reportable format.

• Improves the user management experience for users and internal staff.

• Ensures full traceability.

• Ensures auditability.

1-1

Getting a new password1. On the login page, click Forgot Your Password?.

2. Enter your user name, and click Submit.

Note:

If you forget your user name, contact your Oracle InForm UserManagement Tool Administrator.

3. Enter the answer for your hint question, and click Send New Password.

The new password is sent to the email address associated with your user accountin Oracle InForm User Management Tool.

Changing the login passwordYou need to change your password if it expires or if you exceed the maximum numberof login attempts. Oracle recommends changing your password periodically.

Note:

Passwords expire every 180 days, and passwords need to be reset after 3failed login attempts.

1. In the upper right, from your user name drop-down list, select Change Password.

2. Fill in the fields, and click Submit.

To discard the changes, click Return.

When choosing a password, we recommend that you do not use special or languagespecific characters (for example, question marks or German Umlauts).

If the password you enter is not valid, an error message appears describing thepassword requirements. Passwords should:

• Contain at least 8 characters.

• Not have been used in the previous 5 passwords.

• Contain at least one uppercase and one lower case alphabetic character.

• Contain at least one numeric character.

Viewing audit trailsAll the changes you make in Oracle InForm User Management Tool are recorded bythe system. To view these changes, access the audit trail for the field that changed.

To view the audit trail, click the icon for a field.

Chapter 1Getting a new password

1-2

• To go back to the previous page, click Return.

Logging out of the applicationOracle recommends that you log out of Oracle InForm User Management Tool beforeclosing your browser window.

In the upper right, from your user name drop-down list, select Log Out.

Note:

Oracle InForm User Management Tool automatically logs you out when yoursession is inactive. The inactivity period is set on the UMT Settings page inthe Re-authentication inactivity period field. The default is 30 minutes.

Getting Help• In the upper right, from the Help drop-down list, do one of the following:

– Select HELP.The UMT 12.1 Oracle Help Center page opens in a separate browser windowfrom which you can access the Release Notes and product documentation.

Alternatively, go to http://docs.oracle.com/health-sciences/umt/index.html.

– Select Help Desk Information.The Health Sciences Cloud Support page opens.

Alternatively, go to http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html.

Chapter 1Logging out of the application

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2Regulatory requirements

• Regulatory requirements for Oracle InForm User Management Tool

Regulatory requirements for Oracle InForm UserManagement Tool

You or your delegate are responsible for:

• Ensuring that appropriate regional regulatory approvals are in place beforeallowing a site access to the initial study version or to any subsequent functionalitychanges (for example, a later study version, which may have resulted from aprotocol amendment).This includes ensuring that regional regulatory approvals are in place for any studyversion, even if the study version wasn't yet made available to the site. Forexample, if you're associating a site to study version three, but the site was not yetassociated to study version two, consider whether appropriate regional regulatoryapprovals are in place for study version two for that site before associating the sitewith study version three. This is because associating study version three to thesite will incorporate the functionality changes for study version two as well as studyversion three.

• Ensuring that any user account created through Oracle InForm User ManagementTool accurately reflects the user's training status for the product. Beforedistributing Oracle InForm or Oracle IRT account details to a user, you must markthe user as Trained in Oracle InForm User Management Tool.

These regulatory requirements apply for all Oracle InForm User Management Toolintegrations, specifically Oracle InForm and Oracle IRT.

2-1

3Workflow for giving users access to anOracle InForm study

• About the workflow for giving users access to an Oracle InForm study

• STEP 1: Create the study user account

• STEP 2: Assign and confirm training

• STEP 3: Ensure the study user is trained and approved

• STEP 4: Add the study user to Oracle InForm

• STEP 5: Lock the study in Oracle InForm User Management Tool for development

• STEP 6: Generate and upload the Oracle InForm study data

• STEP 7: Make sure the Oracle InForm study is live

• STEP 8: Send the study user the authorization email with the study URL details

About the workflow for giving users access to an OracleInForm study

Before Oracle InForm access can be provided to a new user, there are a few stepsthat must be completed as a one-time activity by a Oracle InForm User ManagementTool user and by the Oracle InForm study user so that the study user can successfullyaccess an Oracle InForm study.

In Oracle InForm User Management Tool, a customer-delegated Oracle InForm UserManagement Tool user creates the Oracle InForm study users, assigns the requiredtraining, authorizes study access, and sends the authorization email with the studyURL.

Note:

The workflow steps are the same for single sign-on (SSO) and non-SSOusers, except where noted.

STEP 1: Create the study user accountUsers can access Oracle InForm using either a single sign-on (SSO) account, or anon-SSO account. The type of account is determined by the Study Administrator.

How are user accounts created?

A study user can be created manually though the Oracle InForm User ManagementTool user interface, or with the Joint Template (also called the MUL or Master UsersList Template).

3-1

• In the Oracle InForm User Management Tool user interface, create a user, andassign the sites and rights groups the user has access to.For more information, see Creating Oracle InForm or Oracle IRT users and Viewing and modifying user details.

or

With the Joint Template, create and upload a user and their sites and rights.

For information on uploading the template, see Importing administrative data for atrial.

When you create a new user for an SSO study, Oracle InForm User Management Toolchecks to see if the user is already a Global User by matching the user name andemail address against existing Global Users.

• If the user exists, Oracle InForm User Management Tool associates the new studyuser to the existing Global User.

• If the user does not exist in the Global User list, it is automatically created.

The new user appears in the user interface in both the Study Users list and the GlobalUsers list.

For more information, see:

• Single sign-on (SSO) study user accounts

• Non-SSO study user accounts

Single sign-on (SSO) study user accountsFor each Sponsor, Oracle InForm study users can now access all Oracle InFormsingle sign-on (SSO) studies using a single account with one User Name andPassword, which we refer to as a Single sign-on (SSO) or Global User account.

How is an SSO account created?

After you create an SSO user, Oracle InForm User Management Tool communicateswith Oracle Health Sciences Identity and Access Management Service (Oracle HealthIAMS) to create the user's SSO account. For more information, see the Oracle HealthSciences Identity and Access Management Service documentation on the Oracle HelpCenter (https://docs.oracle.com/health-sciences/ohs-iams/index.html).

SSO account emails and account set up

After the SSO account is created, the study user receives one or two emails [email protected] depending on the user's configuration in OracleHealth IAMS

• If, as a Sponsor, you configured the user in Oracle Health IAMS to not requirechallenge security questions, the user will receive one email with their user nameand a link to set up (or reset) their password.

– The link is valid for 5 days.

• If, as a Sponsor, you configured the user in Oracle Health IAMS to requirechallenge security questions, the user will receive two emails. One email containsthe SSO user name, and the other contains a temporary password and a link toreset it and to set up their challenge questions.

– The temporary password must be reset within 90 days

Chapter 3STEP 1: Create the study user account

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If a user doesn't update their password within this time period, they need tocontact their Study Administrator to have the two emails re-sent.

– The challenge questions must be set up within 90 days.The challenge questions are used to verify the user's identity when they usethe Forgot Password feature on the Login page to reset their password if theyforget it, or if their password expires.

If the user doesn't set up the challenge questions, they cannot use the ForgotPassword link to reset their password, and they will need to ask their StudyAdministrator to do it for them.

Note:

Study users only need to set up their SSO account information one time.Therefore, for each SSO account, the one or two emails are only sent thefirst time a study user works on a study for a particular Sponsor. They are notsent for each study.

Managing SSO accounts

After SSO accounts are set up, an Oracle Health Sciences Identity and AccessManagement Service (Oracle Health IAMS) Customer Delegated Administrator (CDA)can manage SSO accounts in Oracle Health IAMS.

• Resetting user SSO passwords

• Locking user SSO accounts

• Unlocking user SSO accounts

Non-SSO study user accountsNon-SSO users are defined in Oracle InForm User Management Tool.

Oracle InForm User Management Tool generates a temporary password for each non-SSO user.

The Oracle InForm User Management Tool user sends the user name and passwordto the user by selecting Send InForm Account Details from the Manage User drop-down list on the Users page. For more information, see Sending user account details.

Note:

A study user is required to change their password during their first login.

STEP 2: Assign and confirm trainingThe study user is required to take training for each Oracle InForm study they will haveaccess to. You can assign the study user to Oracle Health Sciences Learn (HS Learn)training, or you can use an alternate training resource.


Chapter 3STEP 2: Assign and confirm training

3-3

• Oracle Health Sciences Learn (HS Learn) training

• Alternate training resource (optional)

Oracle Health Sciences Learn (HS Learn) trainingTo assign Oracle Health Sciences Learn training to the study user, see Assigning HSLearn classes to a user.

Note:

When you assign a new user to a role that has training associated to it, thetraining is automatically assigned to the user, and this step is not required.The training is not assigned to users already associated with the role.

What happens after the HS Learn training is assigned?

After the Oracle Health Sciences Learn training is assigned, Oracle InForm UserManagement Tool communicates with Oracle Health Sciences Learn, and the studyuser receives one email from [email protected] with the subjectOracle Health Sciences Learn Course Assignment, which is used to access thetraining:

• The first time the study user is assigned to any course by any Sponser.

• When the study user is assigned to the same course by any Sponsor 12 months ormore after the course was most recently completed.

What information is in the HS Learn email?

The Oracle Health Sciences Learn Course Assignment email contains a CompleteTraining Now link.

• If the user has an Oracle account, which is used to access the online training inOracle Health Sciences Learn, a login page appears and the user can log in toOracle Health Sciences Learn to complete the assigned training.

Note:

The Oracle account is not the same as your Oracle Health SciencesIdentity and Access Management Service account.

• If the user doesn't have an Oracle account, they can create one by clicking CreateAccount on the login page.

Note:

When a user takes a course in Oracle Health Sciences Learn, Oracle InFormUser Management Tool is notified and the course completion date willappear in Oracle InForm User Management Tool. After a user has completedall the assigned training, Oracle InForm User Management Tool updates thetraining status of the user to Trained.

Chapter 3STEP 2: Assign and confirm training

3-4

How can users check the training status of a user?

Oracle InForm User Management Tool users can:

• Check the Training Status on the Users page. For more information, see Viewingthe list of Oracle InForm or Oracle IRT users.

• Go to Oracle Clinical One Platform to generate reports or to view the status of theirusers.

Oracle InForm study users can log into Oracle Health Sciences Learn to view, print, ordownload their training completion certificates.

Alternate training resource (optional)If you are using an alternate training resource instead of Oracle Health Sciences Learntraining, after the training is complete, manually mark the user as Trained in OracleInForm User Management Tool.

For more information, see Marking users as trained.

Note:

Marking a user as trained is always a manual process performed thoroughthe user interface; it cannot be done through the Joint (MUL) Template.

STEP 3: Ensure the study user is trained and approvedAll study users must be both Trained and Approved.

• If an Approval process is required for the study, the study user must be manuallymarked as Approved.For more information, see Approving or rejecting users.

• For studies that don't require approvals, new study users are automatically createdand identified in Oracle InForm User Management Tool as Approved.

Note:

If an Approval process is required for a study, the Enforce UM/UA ApprovalProcess option is set to Yes in the Trial Configurations section on theConfiguration > UMT Configuation > Default configuration settingspage.

STEP 4: Add the study user to Oracle InFormAll new study users must be added to Oracle InForm. Oracle InForm users must existbefore the study goes live, and before the study URL details are sent.


• SSO users—Authorize the study user to access the Oracle InForm study

Chapter 3STEP 3: Ensure the study user is trained and approved

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• Non-SSO users—Mark users to upload to Oracle InForm

SSO users—Authorize the study user to access the Oracle InFormstudy

To add an SSO study user to Oracle InForm, you must authorize the user to OracleInForm. Study users must exist in Oracle InForm User Management Tool, OracleHealth IAMS, and Oracle InForm in order for them to be able to log in to a study.

For more information, see Viewing and modifying user details. On the Users page,select the checkbox to the left of the user to authorize. Then, in the Manage Userdrop-down list, select Authorize User, and click Go.

When the authorization is successful:

• The Uploaded to InForm icon ( ) appears to the left of the Username column.

• The word Success appears in the Authorization Status column to show that theuser has been authorized in Oracle Health IAMS.

Non-SSO users—Mark users to upload to Oracle InFormTo add a non-SSO user to Oracle InForm, you must mark the user for upload toOracle InForm. Study users must exist in Oracle InForm User Management Tool andOracle InForm in order for them to be able to log in to a study.

For more information, see Marking users for upload to Oracle InForm or Oracle IRT.On the Users page, select the checkbox to the left of the user to authorize. Then, inthe Manage User drop-down list, select Mark upload to InForm, enter a comment,and click Go.

When the authorization is successful, the Uploaded to InForm icon ( ) appears tothe left of the Username column.

STEP 5: Lock the study in Oracle InForm User ManagementTool for development

Note:

This step is required only before a study goes live; it is not required everytime you add a new user.

In Oracle InForm User Management Tool, make sure the study is locked fordevelopment. When a study is locked for development, you cannot change Roles orGroups, but you can create new users and sites. However, you cannot mark them forupload to Oracle InForm while the study is locked.

For more information, see Locking a trial for development.

Chapter 3STEP 5: Lock the study in Oracle InForm User Management Tool for development

3-6

STEP 6: Generate and upload the Oracle InForm study data

Note:

This step is required only before a study goes live; it is not required everytime you add a new user.

The study data must be generated and uploaded to Oracle InForm. This process isautomated, but can also be done manually.

• To use the automated process, see Generating InForm XML for pre Go-Liveproduction trials.

• To manually generate the Oracle InForm XML (MedML) and enter a ticket to havethe user information uploaded to Oracle InForm, see Generating an Oracle InFormXML ZIP file for upload to Oracle InForm.

STEP 7: Make sure the Oracle InForm study is liveBefore you send the study URL to a study (site) user, make sure that the study is liveand ready for data to be entered.

Note:

When a study is live, Fast Forward appears in the Trial Status column onthe Trials page.

STEP 8: Send the study user the authorization email withthe study URL details

After all other pre-requisites are complete, send the study URL details to the user.

Note:

Sending the authorization email that contains the study URL is always amanual step. SSO and non-SSO study users receive one email with thestudy URL for each study they are given access to.


• SSO users—Send the authorization email

• Non-SSO users—Send the Oracle InForm account details

Chapter 3STEP 6: Generate and upload the Oracle InForm study data

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SSO users—Send the authorization email

Note:

Sending the authorization email that contains the study URL is always amanual step.

How do I send the authorization email to an SSO study user?

To send the study URL details to an SSO study user, you send an authorization emailfrom the Oracle InForm User Management Tool user interface.

For more information, see Sending user account details. On the Users page, selectthe checkbox to the left of the user. Then, in the Manage User drop-down list, selectSend Authorization Email, enter a comment, and click Go.

What happens after the authorization email is sent to the SSO study user?

The study user receives one email for the study they are authorized to accessfrom saasadminsupport_ww with the Subject Line Welcome to <SponsorCustomer Name> <Study Name> trial!.

Note:

Although an SSO study user receives their user credentials email(s) only onetime (see Single sign-on (SSO) study user accounts), an SSO study userreceives a separate email for each study they are given access to becauseeach email contains the study URL.

What information is in the authorization email?

The email contains the user name and study URL link.

Receiving this email confirms that the SSO account and study authorization process iscomplete. Users can log in to the specified study using their SSO user name andpassword.

• If the user is configured to not require challenge security questions, the user hasall the information they need in the authorization email to reset their passwordthemselves.The email contains their user name and the Study URL link. If they go to the StudyURL and choose the Forgot Password link, they will receive an email with a link toreset their password.

• If the user is configured to require challenge security questions, and the questionswere set up previously, the user can reset their own password.

• If the user is configured to require challenge security questions, and the questionswere not set up previously, they cannot reset their own password.Instead, to have their password reset they need to contact their Oracle HealthIAMS Customer Delegated Administrator (CDA) or enter a ticket with OracleGlobal Support.

Chapter 3STEP 8: Send the study user the authorization email with the study URL details

3-8

Non-SSO users—Send the Oracle InForm account details

Note:

Sending the authorization email that contains the study URL is always amanual step.

How do I send the authorization email to a non-SSO study user?

To send the study URL details to a non-SSO study user, you send the Oracle InFormaccount details from the Oracle InForm User Management Tool user interface.

For more information, see Sending user account details. On the Users page, selectthe checkbox to the left of the user. Then, in the Manage User drop-down list, selectSend InForm Account Details, enter a comment, and click Go.

What happens after the authorization email is sent to the non-SSO study user?

The study user receives one email for each study they are authorized to accessfrom saasadminsupport_ww with the Subject Line Oracle – [Customer Name]INFORM [Study Name] - Access Authorization.

What information is in the authorization email?

The email contains the Oracle InForm user name and password, and the study URL.

Receiving this email confirms that the account and study authorization process iscomplete. Users can log in to the specified study or studies using their user name andpassword.

Chapter 3STEP 8: Send the study user the authorization email with the study URL details

3-9

4Managing users

• Oracle InForm and Oracle IRT users

• Oracle InForm User Management Tool users

• Global users

Oracle InForm and Oracle IRT users• Viewing the list of InForm or IRT users

• Creating Oracle InForm or Oracle IRT users

• Viewing and modifying user details

• Viewing the sites a user is associated with

• Associating a user with a site

• Terminating users

• Viewing terminated users

• Unterminating (re-instating) users

• Approving or rejecting users

• Marking users for upload to Oracle InForm or Oracle IRT

• Assigning Oracle Health Sciences Learn classes to a user

• Marking users as trained

• Sending user account details

• Exporting users

• Updating a user's name in email notifications

• Updating assessment status

• Assigning a preferred study locale to a user

Viewing the list of InForm or IRT usersTo view the list of users:

1. Select Users from the menu bar.

2. Select the sponsor company and trial from the Current Sponsor Company andTrial drop-down lists.

To serach for users:

1. Enter the filter criteria, and click Find.

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• The most common filter options appear at the top right of each page. If you donot see the search criteria you want, click More Filters and more criteria willappear.

• If you want to save your filter to use whenever you are on this page, clickSave in the lower right corner of the filter criteria box.

• You can sort the data by clicking on the column header.

2. To clear the filter criteria, click Clear.

Creating Oracle InForm or Oracle IRT usersYou can create site and sponsor users for Oracle InForm or Oracle IRT depending onyour product integration and Oracle InForm User Management Tool privileges.

When creating the user you must assign an Oracle InForm Rights Group and if youare using Oracle IRT, an Oracle IRT role. You can also assign a user to a SignatureGroup and a Query Group.

When you assign a Rights Group to a user, the user will get assigned to any groupsthe role is assigned to. If within a role you want different users assigned to differentSignature Groups or Query Groups you can make those assignments when creatingthe user.



3. On the left, above the Users list, click Create InForm User or Create IRT User.

4. Below Basic User Info, Contact Details, and User Misc enter the user details,and click Submit.

Note:

The available options for the Preferred Study Locale are based on thelanguages specified during the study design. In Oracle InForm, thissetting is used for pages that can span multiple sites, and controls somestudy locale information presented outside of the CRFs, such asheadings on the Time and Events Schedule page or choices in theSource Verification page filter control.

The Product Locale is the language—English or Japanese—of theproduct user interface. Menus, controls, commands, system screenlabels, error messages, and so on are written in the selected language.Oracle creates product locales.

5. Below User Association, select one or more sites to give the user access to, andselect the Rights Groups for the user.

a. Use the Filter By drop-down list to select all sites, all sites in a particular timezone within a country, or all sites in a particular country.

b. Select Automatic Association if you want to automatically associate this userto any sites created in the future for the selected country or timezone.

c. Select the site or sites to give the user access to.

Chapter 4Oracle InForm and Oracle IRT users

4-2

• You can associate a site user with only one site.

• You can associate a sponsor user with multiple sites.

d. Assign the user to a Signature Group and a Query Group.

6. Complete one of the following:

• To save the details and return to the previous page, click Submit and thenclick Return.

Note:

If you added the user to an SSO-enabled trial, when you save thedata Oracle InForm User Management Tool checks to see if theusername, first name, last name, and email id match an existingGlobal User. If not, a Global User will be created.

For production trials, you cannot have more than one user with thesame first name, last name, and email id. Therefore, if the first name,last name, and email id already exists for a Global User but with adifferent username, Oracle InForm User Management Tool displaysan error.

• To save the details and create another user, click Submit and Add Another.

• To discard the details and return to the previous page, click Return.

Viewing and modifying user detailsYou can update the information for an Oracle InForm or Oracle IRT user at any time.Whenever you update the information, Oracle InForm User Management Tool recordsthe changes to ensure that they are auditable.



3. In the Username column, click a user.

4. Modify the user details.

Note:

The available options for the Preferred Study Locale are based on thelanguages specified during the study design. In Oracle InForm, thissetting Is used for pages that can span multiple sites, and controls somestudy locale information presented outside of the CRFs, such asheadings on the Time and Events Schedule page or choices in theSource Verification page filter control.



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5. In the Reason for Change field, enter the reason for modifying the user details.


• To save the changes and return to the previous page, click Submit and thenclick Return.

• To cancel the changes and return to the previous page, click Return.

Viewing the sites a user is associated withWhen viewing the sites that a user is associated with, you can also request anequipment assessment for a site or update the site's assessment status.



3. In the Site(s) column, click the icon.

4. Do one or all of the following:

• To view the site associations for a different user, select the user from theSelect User list and click Go.

• To send an assessment request or update the assessment status for a site,select an option from the Select drop-down list, enter a reason for change,and click Go.


Associating a user with a site

Note:

Before proceeding, ensure that you comply with the regulatory requirementsdescribed in Regulatory Requirements for Oracle InForm User ManagementTool.

If you chose not to associate a user with a site while creating the user, you can do sonow.

• If a user is not associated to any sites in Oracle InForm User Management Tool,the user will not see all the tabs in Oracle InForm.

• Make sure to associate a site to a user before choosing to authorize the user tothe trial that loads the user to Oracle InForm.



3. In the Username column, click a user name.

4. Below User Association, select one or more sites to associate the user with.

a. Use the Filter By drop-down list to select all sites, all sites in a particular timezone within a country, or all sites in a particular country.


4-4

b. Select Automatic Association if you want to automatically associate any newsite that matches the criteria specified for automatic association for the user tothe user.

c. Select the site or sites to give the user access to.

• You can associate a site user with only one site.

• You can associate a sponsor user with multiple sites.

5. In the Reason for change field, enter a reason for change.

6. Click Submit and then click Return.

Terminating usersWhen you terminate a user, you revoke the user's access to a trial.

Note:

For an SSO trial, terminating a user from a trial will not terminate the globaluser. That same global user can be assigned access to another trial in thefuture. If you want to terminate an SSO user across all trials, you mustterminate the user from the Global Users page.



3. Select the checkbox to the left of the user to terminate.

4. Select Terminate User from the Select drop-down list.

5. In the Comments field, enter the reason for terminating the user, and then clickGo.

6. In the confirmation dialog box, click OK.

Note:

To cancel termination of the InForm user, click Cancel.

7. Click OK in the dialog box that appears on successful termination of the OracleInForm user.

Viewing terminated users1. Select Users from the menu bar.


3. In the bottom left, click Terminated User List.



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Unterminating (re-instating) usersIf you need to return a user's access to a trial, you unterminate the user. This task isalso referred to as re-instating a user.



3. In the bottom left, click Terminated User List.

4. Select the checkbox to the left of the user to unterminate, and click UnTerminate.

When you unterminate a user, you need to re-assign the user access to sites.

• If the user had auto-association configured, the user will be assigned to all thesites that currently match the criteria configured for their auto-association.

• If auto-association is not configured for the user, you will need to assign sitesto the user after you unterminate them.

5. In the confirmation dialog box, click OK.


Approving or rejecting users

Note:


You must approve or reject a user after the user is created and if the user details aremodified. When a user needs to be approved or rejected, the user's approval status ischanged to pending on the list of users page.



3. Select the checkbox to the left of the user to approve or reject.

4. From the Select drop-down list, select Approve or Reject.

• If you select Approve, complete the Electronic Signature Affidavit and clickSubmit.

• If you select Reject, enter the reason for rejection in the Comments field.

5. Click Go.


4-6

Marking users for upload to Oracle InForm or Oracle IRT

Note:


To load a user's information from Oracle InForm User Management Tool into OracleInForm or Oracle IRT you must mark the user for upload to a product. Before you canupload a user to a product, the user must be marked as trained in Oracle InForm UserManagement Tool.



3. Select the checkbox to the left of the user to upload.

4. From the Manage User drop-down list:

• For non-SSO users, select Mark Upload to InForm or Mark Upload To IRT.

• For SSO users, select Authorize User, which automatically marks the user forupload to Oracle InForm.

5. Enter the reason for change in the Comments field, and click Go.

When the authorization is successful the following indicators appear on the Userspage:

• For a user in a non-SSO trial or an SSO trial, the Uploaded to InForm icon ( )appears to the left of the Username column.

• For a user in an SSO trial, you must also see the word Success in theAuthorization Status column to show that the user has been authorized in OracleHealth IAMS.

Assigning Oracle Health Sciences Learn classes to a userYou can assign an Oracle Health Sciences Learn class to a user only if you have aOracle InForm User Management Tool-Oracle Health Sciences Learn integration.

To check whether Oracle Health Sciences Learn is enabled for the trial, selectConfiguration from the menu bar; Oracle Health Sciences Learn is enabled for the trialif Switchoff HSLearn in the Trial Configuration section is not selected.

Note:

When you assign a user to a role that has training associated to it, thetraining is automatically assigned to the user. The training is not assigned tousers already associated with the role.


4-7



3. Select the checkbox to the left of the user to assign the Oracle Health SciencesLearn class to.

4. From the Manage User drop-down list, select Assign HS Learn Class.

5. Enter a reason in the Comments field, and click Go.

6. In the Select Classes section, select the Available class or classes to assign tothe user, and move them to the Selected list.

7. Click Submit.

Marking users as trained

Note:


You can mark a user as trained after the user is created and approved.



3. Select the checkbox to the left of the user to mark as trained.

4. From the Manage User drop-down list, select Mark as Trained.

5. Enter the reason for change in the Comments field, and click Go.

Sending user account details

Note:


You can email user account details for an Oracle InForm or Oracle IRT study. To senduser account details, the user must be uploaded to the product and the study must belive.



3. Select the checkbox to the left of the user to send the InForm account details to.


4-8

4. From the Manage User drop-down list:

• For non-SSO users, select Send InForm Account Details.The email contains the Oracle InForm user name and password and the studyURL.

• For SSO users, select Send Authorization Details.The email contains the username and study URL.

5. Enter a comment, and click Go.

Exporting usersYou can export Oracle InForm user details either to an Excel spreadsheet or to a DATfile.



3. Select the checkboxes to the left of the users to export.

4. Above the list of users, do one of the following:

• To export the user details as an Excel spreadsheet, click Export, and selectExport To Excel.

• To export the user details to a DAT file, click Export, and select Export ToFile.

5. In the browser window, click Open or click Save.

Updating a user's name in email notificationsThe Update User Name in Email Notifications option on the InForm Users page letsyou mark users for updating the user name in email notifications.

Note:

This functionality is for non-SSO users only.



3. Select the checkbox to the left of the user to update.

4. From the Manage User drop-down list, select Update User Name in EmailNotifications.

5. From the User Name Order drop-down list, select an option.

6. In the Comments field, enter a reason for change, and click Go.


4-9

Updating assessment statusThe Update Assessment Status option on the InForm Users page lets you update theassessment status of the Oracle InForm users.




4. From the Manage User drop-down list, select Update Assessment Status.


6. Below Update Assessment Status, select an option.

7. In the Assessment Summary Box field, enter a reason for change.

8. Click Update, and then click Return.

Assigning a preferred study locale to a userThe Edit Oracle User Details page lets you assign a preferred study locale to OracleInForm users.




4. From the Select drop-down list, select Assign Preferred Study Locale.

5. From the Language drop-down list, select an option.


Oracle InForm User Management Tool users• Viewing the list of Oracle InForm User Management Tool users

• Creating Oracle InForm User Management Tool users

• Viewing and modifying Oracle InForm User Management Tool user details

• Activating Oracle InForm User Management Tool users

• Terminating Oracle InForm User Management Tool users

• Viewing terminated Oracle InForm User Management Tool users

• Unterminating Oracle InForm User Management Tool users

• Resetting the password for a Oracle InForm User Management Tool user

• Resending Oracle InForm User Management Tool login details

Chapter 4Oracle InForm User Management Tool users

4-10

Viewing the list of Oracle InForm User Management Tool usersThe UMT Users page lets you view the list of Oracle InForm User Management Toolusers and their details. It also lets you filter the Oracle InForm User Management Toolusers based on the filter criteria.

To view the list of users:


2. In the upper left, click UMT Users.

3. From the Current Sponsor Company drop-down list, select the sponsorcompany.

To search for users:






Creating Oracle InForm User Management Tool usersOn successful creation of the Oracle InForm User Management Tool user, the username and temporary password are sent to the email address specified on the CreateUMT User Details page.


2. Click the UMT Users tab.

3. Select the sponsor company from the Current Sponsor Company drop-down list.

4. On the left, above the Users list, click Create UMT User.

5. Enter the user details and select a role.

Note:

Set the Change Password on Next Login option to Yes if you want theOracle InForm User Management Tool user you create to be required tochange their password the first time they login.

6. Select one or more countries and one or more trials to associate the user with.




4-11

• To save the details and create another object, click Submit and AddAnother.


Viewing and modifying Oracle InForm User Management Tool userdetails

The UMT User Details page lets you view and modify Oracle InForm UserManagement Tool user details. If the user details are modified, the reason for changeis captured, and the changes are tracked and audited. You can view the changesmade to a particular field by viewing its corresponding audit trails.










Activating Oracle InForm User Management Tool usersThe UMT Users page also lets you activate Oracle InForm User Management Toolusers.




4. Select the checkbox to the left of the user to activate.

5. From the Select drop-down list, select Activate.

6. In the Comments field, enter the reason for activating the user, and click Go.

Terminating Oracle InForm User Management Tool usersThe UMT Users page lets you terminate Oracle InForm User Management Tool users.You can also view the list of terminated users.





5. From the Select drop-down list, select Terminate.


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6. In the Comments field, enter a reason for terminating the user, and click Go.

Viewing terminated Oracle InForm User Management Tool usersThe Terminated User List page displays the list of terminated Oracle InForm UserManagement Tool users. You can view the user name, first name, last name, andcountry of the terminated users.




4. In the lower left, click Terminated User List.


Unterminating Oracle InForm User Management Tool usersThe Terminated User List page lets you revoke the termination of Oracle InForm UserManagement Tool users. You can either revoke the termination of all users or aparticular user.





5. Select the checkbox to the left of the user to unterminate, and click UnTerminate.


Resetting the password for a Oracle InForm User Management Tooluser

The login password for an Oracle InForm User Management Tool user can be reset incase the password is blocked or expired.




4. Select the checkbox to the left of the user to resend a password for.

5. From the Select drop-down list, select Reset Password.

6. In the Comments field, enter the reason for resetting the password, and click Go.

Resending Oracle InForm User Management Tool login detailsThe UMT Users page also lets you resend Oracle InForm User Management Toollogin details to a user.



4-13



4. Select the checkbox to the left of the user to resend login details to.

5. From the Select drop-down list, select Resend UMT Login Details.

6. In the Comments field, enter the reason for resending the login details, and clickGo.

Global users• Viewing the list of Global users

• Creating Global users

• Assigning a product to a Global user

• Viewing and modifying global user details

• Terminating a Global user

• Viewing the terminated user list

• Unterminating Global users

Viewing the list of Global usersThe Global Users page lets you view the list of Global users and their details. It letsyou filter the Global users based on the filter criteria. You can also associate theproduct to the user here.

To view the list of users:


2. In the upper left, click Global Users.

3. Select the sponsor company from the Current Sponsor Company drop-downlist.

To search for users:



• If yo want to save your filter to use whenever you are on this page, click Savein the lower right corner of the filter criteria box.



Creating Global usersA Global user is a user managed by Oracle Identity Manager suite. Global users mustbe enabled for single sign-on (SSO) and can be site or sponsor users. You can assigna Global user to multiple trials and applications within a sponsor or a CRO. A Global

Chapter 4Global users

4-14

user that has access to applications for multiple sponsors or CROs will have a uniqueidentity per sponsor or CRO.

Note:

Global Users feature is enabled only if Switchoff Global User option (on theConfiguration Settings page) is not selected.




4. On the left, above the Users list, click Create Global User.

5. Enter the user details.

Note:

The Username, First Name, Last Name, and Email Address must beunique.





Assigning a product to a Global userThe Assign Product action item on the Global Users page lets you assign global usersto a product.




4. Select the checkboxes to the left of the user to assign a product to.

5. From the Select drop-down list, select Assign Product.

6. From the Product drop-down list, select the product.

• If you selected InForm:

a. Select the trial version from the Trial Version drop-down list.

b. Select the trial from the Trial drop-down list.

c. If you need to edit the user details, make the changes in the list of Globalusers.

7. Associate the user with a site:


4-15

a. On the far right of the list of users, click the + icon.

b. Select one or more sites to associate the user with.

c. Click Save, and then click OK.

8. In the Comments field, enter a reason for change, and click Submit.

Viewing and modifying global user detailsThe Global User page lets you view and modify Global user details. If the user detailsare modified, the reason for change is captured and the changes are tracked andaudited. You can view the changes made to a particular field by viewing itscorresponding audit trails. If the Global user record is modified, the changes arereflected across all trials the user is associated to.






Note:

When editing a Global user, ensure the User Name, First Name, LastName, and E-mail Address fields are unique.


7. To save the changes and return to the previous page, click Submit and then clickReturn.

To cancel the changes and return to the previous page, click Return.

Terminating a Global userThe Global Users page lets you terminate a Global user.

Caution:

Terminating a Global user will terminate the user across all products the useris assigned to. This means that if you terminate a user on the Global Userspage, it will not only terminate the user from all Oracle InForm studies, it willalso terminate the user from other products that use Oracle Health IAMS forauthentication, such as Oracle Central Coding and Oracle Clinical OnePlatform.





4-16


5. From the Select drop-down list, select Terminate User.

6. In the Comments field, enter the reason for terminating the user, and then clickSubmit.

Viewing the terminated user listThe Terminated User List page displays the list of terminated global users. You canview the user name, first name, last name, country, and email address of theterminated users.






Unterminating Global usersThe Terminated User List page lets you revoke the termination of Global users. Youcan either revoke the termination of all users or a particular user.





5. Select the checkbox to the left of the user to unterminate, and click Unterminate.



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5Managing trials

• Viewing the list of trials

• Viewing and modifying trial details

• Bulk copying

• Selective copying

• Archiving trials

• Viewing archived trials

• Exporting trial details

• Exporting trials

• Importing administrative data for a trial

• Locking a trial for development

• Generating Oracle InForm XML

Viewing the list of trialsThe Trials page lets you view the list of trials and their details. It also lets you filter thetrials based on the filter criteria.

To view the list of trials:

1. Select Trials from the menu bar.


To search for trials:

1. Enter the filter criteria, and click Find





Viewing and modifying trial detailsThe Trial Details page lets you view and modify the trial details. If the trial details aremodified, the reason for change is captured and the changes are tracked and audited.You can view the changes made to a particular field by viewing its corresponding audittrails.

5-1



3. In the Trial Name column, click a trial.

4. Modify the trial details.

5. In the Reason for Change field, enter the reason for modifying the trial details.

6. To save the changes and return to the previous page, click Submit and then clickReturn.

To cancel the changes and return to the previous page, click Return.

Bulk copying

Note:

Bulk copying is available only for non-SSO trials.

You can copy all or selected modules entirely (such as sites, users, and so on) from anon-SSO trial to another non-SSO trial.



3. In the Copy column, click the icon for a trial.

4. In the upper left, click Bulk Copy.

5. From the Source Trial drop-down list, select the source trial.

6. Select the checkboxes to the left of the items to copy.

7. Click Submit, and then click Return.

Selective copying

Note:

Selective copying is available for SSO and non-SSO trials. However, you canonly copy from an SSO trial to another SSO trial, or from a non-SSO trial toanother non-SSO trial.

You can selectively copy a single type of trial data to another trial.



3. In the Copy column, click the Copy icon ( ) for a trial.

4. From the Source Trial drop-down list, select the source trial.

5. From the Select Type drop-down list, select the trial details to copy.

Chapter 5Bulk copying

5-2

Additional checkboxes may appear on the lower left of page, depending on theoption you select.

6. Move the trial details you want to copy from the Available list to the Selected list.

7. Optionally, select the checkboxes at the lower left of the page to copy theadditional data.

For example, if you select Sites from the Select Type drop-down list, theAssociated Sponsor Users and Associated Site Users checkboxes appear onthe page.

• If you select the Associated Sponsor Users checkbox, the sponsor usersthat are associated to the sites you have selected from the source trial arecopied to the destination trial. If you do not select the checkbox, only the siteswill be copied.

• If you select the Associated Site Users checkbox, the site users that areassociated to the sites you have selected from the source trial are copied tothe destination trial. If you do not select the checkbox, only the sites will becopied.


Archiving trialsThe Archive option available on the List of Trials page lets you archive inactive trials.



3. Select the checkbox to the left of the trial to archive.

4. From the Manage Trial drop-down list, select Archive.

5. In the Comments field, enter the reason for archiving the trial, and click Go.

Viewing archived trialsThe List of Archived Trials page lets you view the archived trials. You can view the trialname, reference, protocol number, therapeutic area, and status. This page alsodisplays the date and time of archival.



3. In the lower left, click View Archive of Trials.

• To go back to the previous page, click Back.

Exporting trial detailsOn the Trials page, you can export trial details that appear on the page. You canexport the trial details either to an Excel spreadsheet or to a flat file.



Chapter 5Archiving trials

5-3

3. Select the checkbox to the left of the trial to export.

4. Above the list of trials, do one of the following:

• To export the trial details as an Excel spreadsheet, click Export, and thenselect Export to Excel.

• To export the trials details to a DAT file, click Export, and then select Exportto File.


Exporting trialsClicking Export on the List of Trials page lets you export trials and their associatedsites, site users, sponsor users, roles, and groups.



3. Select the checkbox to the left of the trial to export.

4. Above the list of trials, click Export, and then select Export Trial Data.


Importing administrative data for a trialTo import trial data, you must have the Import Data right.

You can perform a bulk import of trial data using the Master User List (MUL) Template(also referred to as a Joint Template or Composite Template). The template is anExcel spreadsheet you use to create and upload users and their sites and rights. Youcan download this template directly from Oracle InForm User Management Tool.

Note:

For instructions on how to download the template and enter your trial data,see Loading data into the User Management Tool.



3. On the left, above the Trials list, click Upload.

The Upload Data File dialog box appears.

4. In the Filename field, enter the name for your MUL Template, or browse to selectthe template file you want to upload.

5. In the Trial name drop-down list, select the trial name you want to upload data for.

6. In the Import section, select the trial details to import.

7. Click Validate and Import.

Chapter 5Exporting trials

5-4

Locking a trial for developmentWhen a study is locked for development, you cannot change Roles or Groups, but youcan create new users and sites. However, you cannot mark them for upload to InFormwhile the study is locked.



3. Select the checkbox to the left of the trial you want to lock.

4. From the Manage Trial drop-down list, select LockTrial.

5. In the Comments field, enter the reason for locking the trial, and click Go.

6. Complete the Electronic Signature Affidavit, and click Submit.

Generating Oracle InForm XMLThere are two ways to generate Oracle InForm XML to have user informationuploaded to Oracle InForm.

• Automated—For the initial load of Admin data for pre Go-Live production trials,Oracle InForm User Management Tool provides an automated process forgenerating and uploading Oracle InForm Admin data.

• Manual—Create a ZIP file that contains the XML that needs to be uploaded toOracle InForm. Then, enter a ticket with the XML ZIP file attached, to have theuser information uploaded to Oracle InForm.

For more information, see the following:

• Generating Oracle InForm XML for pre Go-Live production trials

• Generating an Oracle InForm XML ZIP file for upload to Oracle InForm

Generating Oracle InForm XML for pre Go-Live production trialsFor the initial load of Admin data for pre Go-Live production trials, Oracle InForm UserManagement Tool provides an automated process for generating and uploadingOracle InForm Admin data. You no longer need to manually generate the OracleInForm XML (MedML) and enter a ticket to have the user information uploaded toOracle InForm.

To use this new feature, you must have the Oracle InForm User Management Toolright, called SendInFormXML (in the User/Sponsor/Site Details category). When youhave this right, the Send to InForm button appears on the Trials page. This feature isfor production trials only; it is not available for UAT trials.



3. Select the checkbox to the left of a trial.

Chapter 5Locking a trial for development

5-5

Note:

Before proceeding to step 4, make sure that the trial is locked for edits,and that the trial has a Fast Start status. This option can only be used fortrials that have the Oracle InForm User Management Tool automation toOracle InForm enabled.

4. Click Send to InForm.

The user receives an email when the load has completed.

• If the load fails, click the icon in the Send To InForm History column on theTrials listing page to view the reason why the load failed, and to see the audithistory of when the Send To InForm button was pressed.

• The Send to InForm button can only be pressed a second time if an erroroccurred during the first load.

• After the Send To Oracle InForm process is completed successfully, anyfuture changes to the data in Oracle InForm User Management Tool will flowdirectly to Oracle InForm. However, data will not flow to Oracle InForm whilethe trial is locked for edits in Oracle InForm User Management Tool.

Generating an Oracle InForm XML ZIP file for upload to Oracle InFormYou can export the details of a trial to an XML file. However, you can export the detailsof only one trial to an XML file at a time.



3. Select the checkbox to the left of a trial.

4. Above the list of trials, click Export, and select Generate InFormXML.

This step creates a ZIP file that contains the XML that needs to be uploaded toOracle InForm.

5. Enter a ticket with the XML ZIP file attached, to have the user informationuploaded to Oracle InForm.

Chapter 5Generating Oracle InForm XML

5-6

6Managing sites

• Viewing the list of sites

• Creating sites

• Viewing and modifying site details

• Changing a site mnemonic

• Approving or rejecting sites

• Marking sites as uploaded to Oracle InForm or Oracle IRT

• Marking sites as not participating

• Viewing not participating sites

• Marking a not participating site as participating

• Assigning or updating the study version

• Exporting sites

• Updating the assessment status for a site

• Sending an assessment email to a site

• Stopping the assessment process for a site

• Assigning a preferred study locale to a site

Viewing the list of sitesThe List of Sites page lets you view the list of sites and site details. This page also letsyou filter the sites based on the filter criteria.

To view the list of sites:

1. Select Sites from the menu bar.

2. Slect the sponsor company and trial from the Current Sponsor Company andTrial drop-down lists.

To search for sites:


• The most common filter options appear at the top right of each page. If you donot see the serch criteria you want, click More Filters and more criteria willappear.




6-1

Creating sitesThe Create Site Details page lets you create sites. Enter the site and user associationdetails to create a new site.



3. On the left, above the Sites list, click Create Site.

4. Enter the site details.

Note:

The Site Study Locale must match the settings of your Oracle InFormstudy. Contact your Oracle Product Manager if you need guidance.

5. Below User Association Details, select the users to associate with the site.





Viewing and modifying site detailsThe Site Details page lets you view and modify site details. When the site details aremodified, the reason for change is captured and the changes are tracked and audited.



3. In the Site Name column, click a site.

4. Modify the site details.

5. In the Reason for Change field, enter the reason for modifying the site details.




Chapter 6Creating sites

6-2

Changing a site mnemonicIn Oracle InForm User Management Tool, you can change the site mnemonic throughthe user interface. However, in the MUL Template or the .DAT file, the site mnemonicis the unique identifier for the site, and it cannot be changed.

If you need to change a site mnemonic, we recommend you edit the site through theuser interface. For more information, see Viewing and modifying site details.

If you want to change a site mnemonic using the MUL Template or .DAT file, you can:

1. Create a new site with the new mnemonic and same name as an existing site.

For more information, see Creating sites.

2. Associate any site or sponsor users assigned to the existing site to the new site.

Some users may be automatically assigned to the new site due to an auto-association.

For more information, see Associating a user with a site.

3. Terminate the site with the original mnemonic.

Approving or rejecting sites

Note:


The List of Sites page lets you approve and reject sites. A site must be approvedbefore you carry out any clinical trials.



3. Select the checkbox to the left of the site to approve or reject.




5. Click Go.

Chapter 6Changing a site mnemonic

6-3

Marking sites as uploaded to Oracle InForm or Oracle IRT

Note:


To upload site details to Oracle InForm or Oracle IRT you must mark the site forupload in Oracle InForm User Management Tool.



3. Select the checkbox to the left of the site to mark for upload to Oracle InForm.

4. From the Select drop-down list, select Mark Upload To InForm or Mark Uploadto IRT.

5. In the Comments field, enter the reason for change, and click Go.

Marking sites as not participatingSites which no longer participate in a trial can be marked as not participating, makingthem inactive in the study. The site user accounts associated only with the not-participating site are marked as terminated.



3. Select the checkbox to the left of the site to mark as not participating.

4. From the Select drop-down list, select Mark as Not Participating.


Viewing not participating sitesYou can view the list of not participating sites under the trial of a sponsor company.



3. In the lower left, click View Not Participating Sites.


Chapter 6Marking sites as uploaded to Oracle InForm or Oracle IRT

6-4

Marking a not participating site as participatingYou can mark a not participating site as participating again. Users associated withsuch sites are no longer considered terminated.



3. In the lower left, click View Not Participating Sites.

4. Select the checkbox to the left of the site to mark as participating.

5. Click Mark as Participating.

• When a site is terminated (marked as not participating) and then reinstated(marked as participating):

– The same criteria that is used for the automatic association of users tonew sites is used for the reinstated site.

– The audit history in the Sites tab now tracks when a site is terminated andthen reinstated. To see the audit history, click the History icon for the SiteNumber field on the Site Details page.

• If the Oracle InForm User Management Tool configuration setting DefaultStudy Version is set to Multiple, you can select a specific study version whenyou reinstate a site through the user interface.

6. To go back to the previous page, click Return.

Assigning or updating the study version

Note:


You can assign a study version to a site or update the study version after you havemodified a site.



3. Select the checkbox to the left of the site to update the study version for.

4. From the Select drop-down list, select Assign study version.

5. From the study version drop-down list, select the study version.


Chapter 6Marking a not participating site as participating

6-5

Exporting sitesThe Export to Excel and Export to File links available on the List of Sites page let youexport site details to an Excel spreadsheet or a DAT file.



3. Select the checkbox to the left of the site to export.

4. Above the list of sites, do one of the following:

• To export the site details as an Excel spreadsheet, click Export to Excel.

• To export the site details to a DAT file, click Export to File.


Updating the assessment status for a siteThe List of Sites page also lets you update the assessment status for a site.



3. Select the checkbox to the left of the site to update.

4. From the Select drop-down list, select Update Assessment Status.


6. Select an assessment status to assign to all users associated with the site.

7. In the Assessment Summary Box field, enter the reason for change.


Sending an assessment email to a siteThe List of Sites page lets you send an assessment email for a site.



3. Select the checkbox to the left of the site to send an assessment email to.

4. From the Select drop-down list, select Send Assessment Email.


Stopping the assessment process for a siteThe List of Sites page lets you stop the assessment process for a site.


Chapter 6Exporting sites

6-6


3. Select the checkbox to the left of the site to stop the assessment process for.

4. From the Select drop-down list, select Stop Assessment Process.


Assigning a preferred study locale to a siteThe List of Sites page lets you assign a preferred study locale for a site.



3. Select the checkbox to the left of the site to update.

4. From the Select drop-down list, select Assign Preferred Study Locale.

5. From the Language drop-down list, select the study locale.


Chapter 6Assigning a preferred study locale to a site

6-7

7Managing roles

• Managing Oracle InForm roles

• Managing Oracle IRT roles

• Managing Oracle InForm User Management Tool roles

Managing Oracle InForm roles• Viewing the list of Oracle InForm roles

• Creating Oracle InForm roles

• Viewing and modifying Oracle InForm role details

• Assigning an Oracle InForm role to a user

• Assigning Oracle Health Sciences Learn classes to a role

• Setting the display override option

• Approving or rejecting Oracle InForm roles

• Transferring Oracle InForm roles

Viewing the list of Oracle InForm rolesThe InForm Roles page lets you view the list of Oracle InForm roles and its details. Italso lets you filter roles based on the filter criteria.

To view the list of roles:

1. Select Roles from the menu bar.

2. Select the sponsor company and trial from the Current Sponsor Company andTrial drop-down list.

To search for roles:



Creating Oracle InForm rolesThe Create InForm Role page lets you create a role, assign its rights, and select thetraining classes you want assigned to the role. You can assign the roles to each user,which defines the access level of the account to the system.

When a new user is created and associated to this role, the selected training classeswill automatically be assigned to the user. The training is not assigned to users alreadyassociated with the role.


7-1


3. On the left, above the Roles list, click Create InForm Role.

4. Enter the role details.

5. In the Select Classes section, select the training classes you want to assign tothis role.

Note:

When a new user is created and associated to this role, the selectedtraining classes will automatically be assigned to the user. The training isnot assigned to users already associated with the role.





Viewing and modifying Oracle InForm role detailsThe InForm Role Details page lets you view the rights associated with a role andmodify the details, if required. When role details are modified, the reason for change iscaptured and the changes are tracked and audited. You can view the changes madeto a particular field by viewing its corresponding audit trails.



3. In the Role Name column, click a role.

4. Modify the role details.

Note:

To associate users to a role, click the Associate Users icon ( ) to theright of the Role field.

5. In the Reason for Change field, enter the reason for modifying the role details.




Chapter 7Managing Oracle InForm roles

7-2

Assigning an Oracle InForm role to a userThe User-Role Association page lets you view the list of users associated with theselected role. You can also add or remove users for the selected role.



3. In the User Association column, click the icon for a role.

4. Select the users to give the role to.

When you assign a user to a role that has training associated to it, the training isautomatically assigned to the user. The training is not assigned to users alreadyassociated with the role.


Assigning Oracle Health Sciences Learn classes to a roleTo check whether Oracle Health Sciences Learn is enabled for the trial, selectConfiguration from the menu bar; Oracle Health Sciences Learn is enabled for thetrial if Switchoff HSLearn in the Trial Configuration section is not selected.

Note:

When you assign a user to a role that has training associated to it, thetraining is automatically assigned to the user. The training is not assigned tousers already associated with the role.



3. Click the Role Name link, and scroll down to the bottom of the Role Details page.

4. In the Select Classes section, select the Available class or classes to assign tothe role, and move them to the Selected list.

5. Click Submit.

Setting the display override optionThe Change Display Overrides page lets you set the display override option for anitem group.

Note:

For Oracle InForm 6.1 and above, display overrides should only be definedin Oracle Central Designer and not Oracle InForm User Management Tool.

Chapter 7Managing Oracle InForm roles

7-3



3. In the Display Override column, click the icon for a role.

4. Select the item groups for the display override, and then select Read-only,Editable, or Hidden.


Approving or rejecting Oracle InForm rolesThe InForm Roles page lets you approve and reject Oracle InForm roles. You caneither approve or reject Oracle InForm roles depending on your access rights. You canapprove or reject only those roles which are in the Pending status.



3. Select the checkbox to the left of the role to approve or reject.




5. Click Go.

Transferring Oracle InForm rolesThe InForm Roles page also lets you transfer Oracle InForm roles.



3. In the Transfer Role column, click the icon for a role.

Note:

At least one user must be associated to the role.

4. Select one or more users from the User(s) Available list, and click the arrowbuttons to move them to the Transfer to list.

5. From the Transfer to drop-down list, select a role to transfer the user to.


Managing Oracle IRT roles• Viewing the list of Oracle IRT roles

Chapter 7Managing Oracle IRT roles

7-4

• Creating Oracle IRT roles

• Approving or rejecting Oracle IRT roles

Viewing the list of Oracle IRT rolesThe IRT Roles page lets you view the list of Oracle IRT roles and role details. Thispage also lets you filter the Oracle IRT roles based on the filter criteria.

To view the list of Oracle IRT roles:


2. In the upper left, click IRT Roles.


To search for Oracle IRT roles:



Creating Oracle IRT rolesThe Create IRT Role page lets you create a role and assign rights under variouscategories such as Subject Related, Study Admin Activities, Site Admin Activities,User Related Activities, Drug Related Activities, Reports, Ad-Hoc Reports, andInstructions and Forms. You can assign all or some of the rights under each categoryto a user.


2. On the left, click the IRT Roles tab.


4. On the left, above the Roles list, click Create IRT Role.

5. Enter the role details.





Approving or rejecting Oracle IRT rolesThe IRT Roles page lets you view approve or reject Oracle IRT roles.


2. In the upper left, click IRT Roles.


Chapter 7Managing Oracle IRT roles

7-5

4. Select the checkbox to the left of the role to approve or reject.

5. In the Comments field, enter a reason for change, and then click Go.

Managing Oracle InForm User Management Tool roles• Viewing the list of Oracle InForm User Management Tool roles

• Creating Oracle InForm User Management Tool roles

• Oracle InForm User Management Tool roles and rights

• Viewing and modifying Oracle InForm User Management Tool role details

• Assigning a Oracle InForm User Management Tool role to a user

• Deleting Oracle InForm User Management Tool roles

Viewing the list of Oracle InForm User Management Tool rolesThe UMT Roles page lets you view the list of Oracle InForm User Management Toolroles and role details. This page also lets you filter the Oracle InForm UserManagement Tool roles based on the filter criteria.

To view the list of Oracle InForm User Management Tool roles:


2. In the upper left, click UMT Roles.


To search for Oracle InForm User Management Tool roles:



Creating Oracle InForm User Management Tool rolesThe Create UMT Role page lets you create a role and assign rights under variouscategories such as UMT Admin, Import, Export, User, Sponsor, Site Details, Log Files,Approval, InForm Rights, and Miscellaneous. You can assign all or some of the rightsunder each category to a user.


2. On the left, click the UMT Roles tab.


4. On the left, above the Roles list, click Create UMT Role.

5. Enter the Oracle InForm User Management Tool role details.




Chapter 7Managing Oracle InForm User Management Tool roles

7-6


Oracle InForm User Management Tool roles and rightsOracle InForm User Management Tool roles are assigned certain rights and privilegesthat help them perform different tasks.

Note:

If you are a Oracle InForm User Management Tool Admin who creates andmodifies Oracle InForm User Management Tool roles in Oracle InForm UserManagement Tool, if you do not see one of the rights listed in this sectionand want to grant that right to a Oracle InForm User Management Tool role,you must enter a ticket in the HSGBU Support Cloud (https://hsgbu.custhelp.com) to request the right to be added to the appropriateAdmin role for your Sponsor. After the right is added you can assign it to anyOracle InForm User Management Tool role.

• UMT Admin rights

• Import/Export rights

• User/Sponsor/Site details rights

• Log file rights

• Approval rights

• InForm rights

• Miscellaneous rights

UMT Admin rights

Rights Description

Create UMT User Create a Oracle InForm User ManagementTool user.

Modify UMT User Edit Oracle InForm User Management Tooluser details.

View UMT User View Oracle InForm User Management Tooluser details.

Manage UMT User Edit Oracle InForm User Management Tooluser country details and user association withtrials.

Create UMT Role Create a Oracle InForm User ManagementTool role.

Modify UMT Role Sponsor Role Users: Modify sponsor roleuser details.

PF Role Users: Update default role settings ofPF role.

View UMT Role View Oracle InForm User Management Tooluser role details.


7-7



Rights Description

Manage UMT Role Edit the association between a user and arole.

Manage HSLearn Training Configure and edit Oracle Health Learnsettings.

Manage SSO Authorize a user to an Oracle InForm study.

Send the authorization email to an OracleInForm SSO user.

Assign SSO Role Give access to the SSO Roles tab in OracleInForm User Management Tool, which showsall sponsor type global users for a tenant andlets you assign particular CDA rights forOracle Health IAMS to any of these users.

Assign the Assign SSO Role right to giveusers access to all sponsor type global usersfor the a tenant.

Note:

When youupgrade yourproductionOracle InFormUserManagementToolenvironment tothe OracleInForm UserManagementTool 12.0.5release, anyOracle InFormUserManagementTool role thatpreviously hadthe ManageSSO right willnow have boththe ManageSSO and AssignSSO Role right.

Import/Export rights

Rights Description

Import/Export Import and export trial details.

Import Form and Items Ref Names Import XML forms and item ref names.

Manage Auto Import Duplicates Resolve automatically duplicated trial items.


7-8

User/Sponsor/Site details rights

Rights Description

Create Sponsor Create a sponsor.

Modify Sponsor Details Edit sponsor details.

View Sponsor Details View sponsor details.

Create Trial Create a trial.

Modify Trial Details Edit trial details.

Create InForm User Create Oracle InForm user.

Modify InForm User Edit Oracle InForm user details.

View InForm User View Oracle InForm user details.

Manage InForm User Associate a group and a role.

Create Site Create a site.

Modify Site Edit site details.

View Site Details View site details.

Manage Site Details Create and modify user and site association.

Load to InForm Load user and site details to Oracle InForm.

Copy Between Trials Copy trial.

Manage Mass Associations Enable mass association.

Lock Trial Rights to lock trials.

View/Edit Pivotal Fields Rights to view or edit Pivotal details.

Create/Edit UAT details Rights to create or edit UAT details.

View Terminated User Details Rights to view the terminated user details.

View IRT User Details Rights to view the Oracle IRT user details.

View IRT Site Details Rights to view the Oracle IRT site details.

View IRT Right and Roles Rights to view the Oracle IRT right and roles.

Manage IRT User Details Rights to edit the Oracle IRT user details.

Manage IRT Site Details Rights to edit the Oracle IRT site details.

Manage IRT Right and Roles Rights to edit the Oracle IRT right and roles.

Load to IRT Load user and site details to Oracle IRT.

SendInFormXML Gives access to the Send to InForm buttonon the Trials page

Use this button to bulk load Admin data to apre Go-Live production trial. For moreinformation, see Generating Oracle InFormXML for pre Go-Live production trials.

Log file rights

Rights Description

View Import/Export Log File View Oracle InForm User Management ToolImport Excel for Oracle InForm application logfiles.


7-9

Approval rights

Rights Description

Approve Site Details Approve or reject site details.

Approve InForm User Details Approve, reject or terminate Oracle InFormuser.

Approve InForm Rights and Role Approve or reject Oracle InForm role.

Approve InForm Groups Approve or reject Oracle InForm group.

Approve InForm Configuration Approve or reject Oracle InForm settings.

Approve IRT Rights and Role Approve or reject Oracle IRT role.

InForm rights

Rights Description

Edit InForm Config Settings Edit the Oracle InForm configuration settings.

Create InForm Rights and Role Create Oracle InForm rights and roles.

Modify InForm Rights and Role Edit Oracle InForm rights and roles.

Manage InForm Rights and Role Manage the user-role associations.

Create InForm Groups Create Oracle InForm group details.

Modify InForm Groups Edit Oracle InForm group details.

Manage InForm Groups To enable user, role association with groups.Associate an Oracle InForm group with a userand a group.

View InForm Config View Oracle InForm configuration details.

View InForm Rights and Roles View Oracle InForm rights and roles.

View InForm Groups View Oracle InForm groups.

Miscellaneous rights

Rights Description

View Reports To view the billing details report, trainingreport, and assessment detail report.

Viewing and modifying Oracle InForm User Management Tool roledetails

The UMT Role Details page lets you view the rights associated with a role and modifythe details, if required. If the role details are modified, the reason for change iscaptured and the changes are tracked and audited. You can view the changes madeto a particular field by viewing its corresponding audit trail.




7-10


4. In the Role Name column, click a role.

5. Modify the Oracle InForm User Management Tool role details.

6. In the Reason For Change field, enter the reason for modifying the role details.




Assigning a Oracle InForm User Management Tool role to a userThe User-Role Association page lets you view the list of users associated with theselected role. You can also add or remove users for the selected role.




4. Click the icon for a role.

5. Select the users to assign to the role.


Deleting Oracle InForm User Management Tool rolesThe UMT Roles page lets you delete roles. However, you must specify the reason fordeleting the Oracle InForm User Management Tool role.




4. Select the checkbox to the left the role to delete.

5. In the Comments field, enter the reason for deleting the role and then clickDelete.


7-11

8Managing groups

• Viewing the list of groups

• Creating groups

• Importing group data from Oracle Central Designer with the Shell Report

• Viewing and modifying user and group associations

• Validating AutoQuery groups

• Viewing and modifying group details

• Approving or rejecting groups

Viewing the list of groupsThe List of Groups page lets you view the list of groups and their details. It also letsyou filter groups based on the filter criteria.

To view the list of groups:

1. Select Groups from the menu bar.


To search for groups:



Creating groups1. Select Groups from the menu bar.


3. On the left, above the Groups list, click Create Group.

4. Enter the group details.





8-1

Importing group data from Oracle Central Designer with theShell Report

For Oracle InForm 6.1 and above, Display Overrides and System configurationsettings are defined in Oracle Central Designer and not Oracle InForm. Rights Groupsthat need Display Overrides need to be defined in Oracle Central Designer as well.

Signature Group content should be defined in Oracle Central Designer. Query Groupnames may be defined in Oracle Central Designer as well.

Signature Groups, Rights Groups and Query Groups must also be defined in OracleInForm User Management Tool to assign roles/users to them. If this is done manually,there is a risk of introducing errors.

The information defined in Oracle Central Designer can be exported to an XML filecalled a Shell Report. You can import the Shell Report into Oracle InForm UserManagement Tool to load the data defined in Oracle Central Designer into OracleInForm User Management Tool. Users or roles can then be assigned to these groups,and the system configuration settings will be set.

Note:

Item groups and display overrides should only be defined in Oracle CentralDesigner. Importing the Shell Report will not import these into Oracle InFormUser Management Tool. Importing the Shell Report will only import signaturegroups, rights groups and query groups.


2. Select the trial from the Trial drop-down list.

3. On the left, click Import Shell Report.

4. In the Import Shell Report dialog box, browse to the XML file created in OracleCentral Designer, and click Import.

Viewing and modifying user and group associationsYou can view users associated with a group and modify the number of usersassociated with it.



3. In the User Association column, click the icon for a group.

4. Select the users to include in the group.


Chapter 8Importing group data from Oracle Central Designer with the Shell Report

8-2

Validating AutoQuery groupsYou can validate approved autoquery groups for the purpose of uploading XML formsinto Oracle InForm.



3. Below the list of groups, click AutoQuery/CTValidation.

4. Select the AutoQuery User and the CT Validation User.


Viewing and modifying group detailsThe Edit Groups page lets you view and modify group details. If the group details aremodified, the reason for change is captured and the changes are tracked and audited.You can view the changes made to a particular field by viewing its corresponding audittrails.



3. In the Group Name column, click a group.

4. Modify the group details.

5. In the Reason For Change field, enter a reason for change.


Approving or rejecting groupsThe List of Groups page lets you approve and reject groups. You can approve or rejectgroups depending on your access rights. All changes made to the group must beapproved.



3. Select the checkbox to the left of the group to approve or reject.

4. From the Manage Group drop-down list, select Approve or Reject.



Chapter 8Validating AutoQuery groups

8-3

9Managing reports

• Generating reports

Generating reports1. Select Reports from the menu bar.

2. On the left, select a type of report.

3. On the right, select the report to run.

4. Fill in the fields, and click Generate.

• To download the report as an Excel spreadsheet, click Export to Excel.

• To download the report as a DAT file, click Export to File.

• To print the report, click Print.

9-1

10Managing assessment

• Viewing the list of assessed users

• Updating assessment status for an assessed user

• Viewing assessment comment history

• Adding, editing, and deleting assessment comments

Viewing the list of assessed usersThe List of Assessed Users page lets you view the list of assessed users and theirdetails. Additionally, it lets you filter the users based on the filter criteria.

To view the list of assessed users:

1. Select Assessments from the menu bar.


3. From the Site drop-down list, select the site associated with the assessed users.

To search for assessed users at a site:



Updating assessment status for an assessed userThe List of Assessed Users page lets you update the assessment status of assessedusers.





5. From the Select drop-down list, select Update Assessment Status.

6. In the Comments field, enter the reason for the update, and then click Go.

7. Below Update Assessment Status, select an option.

8. Enter a summary of the update in the Assessment Summary Box field.


10-1

Viewing assessment comment historyThe List of Assessed Users page also lets you view the Assessment Comment Historyfor an assessed user.




4. In the right-most column, click the book icon for a user.


Adding, editing, and deleting assessment commentsThe Add New Comments link on the Assessments Comments History Page lets youadd new comments to an assessed user’s comments history. The Edit or Delete linkon the Assessment Comments History page lets you edit or delete comments from anassessed user’s assessments comments history.

To add comments:




4. In the right-most column, click the book icon for a user.

5. Click Add New Comments.

6. Enter the comments in the Public Comments and Private Comments fields.

Note:

You must enter comments in both fields.

7. Click Submit.


• To clear the entered comments, click Clear.

To edit comments:

1. Click Edit/Delete on a comment.

2. Edit the comment.

Chapter 10Viewing assessment comment history

10-2

Note:

In the Comment Type column, you can change the comment to public orprivate.

3. Below the list of comments, enter the reason for change in the Comments field.

4. In the Edit/Delete column for a comment, click Update.


To delete comments:

1. Click Edit/Delete on a comment.

2. Below the list of comments, enter the reason for deletion in the Comments field.

3. In the Edit/Delete column, click the trash can icon.


Chapter 10Adding, editing, and deleting assessment comments

10-3

11Managing log files

• Viewing the list of log files and transferred data

• Archiving log files

• Viewing archived log files

Viewing the list of log files and transferred dataThe Log Files page displays the list of log files and its details.

1. Select Log Files from the menu bar.


3. Enter the filter criteria and click Find.

• To view the list of transferred data, click HTML Log View.

• To clear the filter, click Clear.

Archiving log filesThe Archive option available on the Log Files page lets you archive inactive log files.




4. Select the checkbox to the left of the log file to archive.

5. In the Comments field, enter the reason for change, and click Archive.

Viewing archived log filesThe List of Archived Log Files page lets you view archived log files. You can view theapplication name, module name, name of the user who initiated the import, date andtime of the import, and status of the import.



3. In the lower left, click View Archive of Log Files.

• To view list of transferred data, click Batch ID.


11-1

12Oracle Health Sciences Learn (HS Learn)training

• Assigning an Oracle Health Sciences Learn class to a trial

• Managing training

Assigning an Oracle Health Sciences Learn class to a trial

Note:

You must disable the Switchoff HSLearn option before you can assignOracle Health Sciences Learn classes for a trial. To check whether OracleHealth Sciences Learn is enabled for the trial, select Configuration from themenu bar; Oracle Health Sciences Learn is enabled for the trial if SwitchoffHSLearn in the Trial Configuration section is not selected.

1. Select HSLearn Training from the menu bar.


3. In the Assign Classes to Trial tab, select the classes to assign to the trial andspecify a number of seats.

4. Click Submit.

You can also assign Oracle Health Sciences Learn training to a user or a role. Formore information, see:

• Assigning HS Learn classes to a user

• Assigning HS Learn classes to a role

Managing trainingThe Manage Training page lets you view the list of classes assigned to the users andtheir statuses, and to assign and reassign classes to the users.

1. Select HSLearn Training from the menu bar.


3. On the left, click the Manage Training tab.


Oracle InForm User Management Tool users can go to Oracle Clinical One Platform togenerate reports or to view the status of their users.

12-1

Oracle InForm study users can log into Oracle Health Sciences Learn to view, print, ordownload their training completion certificates.

Chapter 12Managing training

12-2

13Configuring settings

• Configuring Oracle InForm settings

• Oracle InForm User Management Tool Settings

• Configuring assessment

• Configuring assessment benchmark

Configuring Oracle InForm settingsThe Configuration settings page lets you configure Oracle InForm settings such aseditable system configuration and general settings.

Note:

For Oracle InForm 6.1 and above, most Oracle InForm configuration optionswill be grayed out because these should be configured in Oracle CentralDesigner instead.

• Configuring editable system configuration options for trials on the trial level

• Configuring editable system configuration options for new and existing trials on thesponsor company level

• Configuring a custom review state

• Exporting Oracle InForm configuration settings

Configuring editable system configuration options for trials on the triallevel

The Editable System Config Options section lets you configure editable systemconfiguration options for a selected trial.

1. Select Configuration from the menu bar.


3. Enter the settings required.

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Note:


4. Enter the reason for modifying the settings in the Comments field, and clickSubmit.

5. To discard the changes, click Return.

Configuring editable system configuration options for new and existingtrials on the sponsor company level

You can also configure the editable system configuration options for a new trial andupdate the settings for all existing trials under the selected sponsor company in theEditable System Config Options section.


2. Select the current sponsor company from the Current Sponsor Company drop-down list, and All from the Trial drop-down list.

3. Enter the settings in the Editable System Configuration Options section.

4. Select the check boxes corresponding to the setting items under the EditableSystem Config Options section.

This updates all existing trials and sets the default value for new trials to becreated under the selected sponsor company.

Note:




Configuring a custom review stateThe Custom Review settings page lets you configure custom review states andcustom review stages for Oracle InForm 5.5 trials. Custom Review states should bedefined in Oracle Central Designer only for Oracle InForm 6.0 and above.


2. Click Custom Review State Config.


Chapter 13Configuring Oracle InForm settings

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Note:

Select an Oracle InForm 5.5 trial.

4. Enter the settings.

5. Enter the comments for modifying the configurations in the Comments field, andclick Submit.

6. Click Remove Review Stage to delete the custom review stages.

Exporting Oracle InForm configuration settingsThe Export to Excel and Export to File links available on the Configuration settingspage let you export configuration settings. You can export the settings to an Excelspreadsheet or to a flat file.



3. Click the Export to Excel or Export to File.


Oracle InForm User Management Tool Settings• Configuring Oracle InForm User Management Tool settings

• Configuring default trials, sites, and user settings

• Exporting Oracle InForm User Management Tool configuration settings

Configuring Oracle InForm User Management Tool settingsThe UMT Settings page lets you view and configure the password and login settings,worklist schedule, and staging schedule settings. The password assigned to theOracle InForm User Management Tool users during creation is based on the settingsconfigured on the UMT Settings page.

1. Select UMT Settings from the menu bar.

2. Modify the Oracle InForm User Management Tool configuration settings.

3. Enter the reason for modification in the Reason for change field, and clickSubmit.


Configuring default trials, sites, and user settingsThe Configuration settings page lets you configure Oracle InForm User ManagementTool settings for trial configuration, site configuration, and user configuration. Newsites and Oracle InForm users created under a selected trial reflect these settings.


Chapter 13Oracle InForm User Management Tool Settings

13-3


3. Select UMT Config.

4. Enter the settings in the Trial Configurations sections.

Note the following fields:

• Sponsor Name for UMT Mails—Select the required option to use the sponsorname for Oracle InForm User Management Tool mails. The available optionsare:

– Append Sponsor name with Sponsor Customer Name—Select thisoption to append sponsor name with sponsor customer name.

– Replace Sponsor name with Sponsor Customer name—Select thisoption to replace sponsor name with sponsor customer name.

• Free Phone Number URL—Select the required free phone number URL. Theavailable options are:

– Oracle Helpdesk

– Sponsor Specific—If you select Sponsor Specific, enter the URL in theSponsor Specific URL text box.

5. Enter the settings in the Site Configuration sections.

Note the following field:

• Default Study Version

– Latest—Select this option to set the latest study version as the default.New sites and reinstated sites will always be assigned the latest studyversion.

– Multiple—Select this option to set multiple study versions as the default.You can select a specific study version for newly created sites and forreinstated sites. For more information, see Marking a not participating siteas participating.To add a new study version, select Multiple.

6. Enter the settings in the User Configuration sections.



Exporting Oracle InForm User Management Tool configurationsettings

The Export to Excel and Export to File links available on the Configuration settingspage lets you export Oracle InForm User Management Tool configuration settings.You can export the settings to an Excel spreadsheet or to a flat file.



3. Click the Export to Excel or Export to File.

Chapter 13Oracle InForm User Management Tool Settings

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Configuring assessmentThe Assessment Configuration Settings page lets you configure the assessmentsettings at sponsor level and trial level.


2. Click Assessment Config.




Configuring assessment benchmarkThe Assessment Benchmark Settings page lets you configure the benchmark settingsfor assessment.


2. Click Assessment Benchmark.


Note:

You can configure the benchmark settings for assessment on thesponsor company level by not selecting a trial.



Chapter 13Configuring assessment

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14Loading data into the Oracle InForm UserManagement Tool

• About loading data into the Oracle InForm User Management Tool

• Using the MUL Template to add or change data

• Creating a master template from the MUL Template

• Entering data in the MUL Template

About loading data into the Oracle InForm UserManagement Tool

You can create users and assign sites and user rights in the Oracle InForm UserManagement Tool user interface. However, to upload large amounts of user and sitedata, Oracle recommends that you perform a bulk import from a Microsoft Excelspreadsheet. To facilitate this process, Oracle provides a Master User List (MUL)Template (also referred to as a Joint Template or Composite Template) to create andupload users and their sites and rights. You can download this template directly fromOracle InForm User Management Tool.

Note:

Existing templates in the previous format from Oracle InForm UserManagement Tool 12.0.5.1 can still be imported into Oracle InForm UserManagement Tool 12.1. However, Oracle recommends that you transfer datato the new templates as quickly as possible. Future releases of OracleInForm User Management Tool 12.1 will not support importing older versionsof the template.

This template can be used for multiple workflows:

• To update data for a specific trial.Download the template specifying an existing trial. You can then add or changeexisting data for this trial in the spreadsheet and re-import the data as needed. Formore information, see Using the MUL Template to add or change data.

• To create a template to use as a common starting point for all trials.Download the template without specifying a trial. This allows you to reuse a singletemplate with common rights and roles as a starting point for all trials.

For example, if you use the same Rights & Roles for all of your trials, you couldpopulate them in the template and then use that template as the starting point forall of your trials.

For more information, see Creating a master template from the MUL Template.

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Regardless of which workflow you are using:

• You must have macros enabled.

• Columns labeled in blue are required fields and must be populated.

• Ensure that no blank rows exist between completed rows.

• For Oracle InForm 6.0 and above, Oracle recommends that the username is set tothe user’s email address (for example, [email protected] ).The character length of the username cannot exceed 63 characters. As analternative, you can use the first initial plus the last name. For example, theusername for the user John Doe is jdoe.

• Site numbers must include all digits, including leading zeros.

• Do not use special or foreign characters in template cells.

• You cannot have duplicate sites or users.

• Do not use carriage returns when entering address data.

• If you copy and paste into cells with drop-down lists, be sure the value exactlymatches the value provided in the drop-down list.

• Updating your Excel options

Updating your Excel optionsDepending on how your Excel options are configured, you may see an Excel error icon

( ) in the Oracle InForm Version field on the Welcome page after you open atemplate that you downloaded from Oracle InForm User Management Tool usingMicrosoft Excel.

You can ignore the icon and associated message, or you can update your Exceloptions to remove it.

To remove the icon:

1. Click in the version number box to display the icon in the InForm Version labelfield.

Chapter 14About loading data into the Oracle InForm User Management Tool

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2. Hover over the Excel error icon, and select Error Checking Options from themenu.

3. In the Excel Options dialog box, in the Error checking rules section, deselect theNumbers formatted as text or preceded by an apostrophe option.

4. Click OK.

Using the MUL Template to add or change dataIf you want to change, delete, or add data for an existing trial using the MUL Template,you must:

1. Use the Oracle InForm User Management Tool user interface to download theMUL (Composite) template with your trial data.

2. Update the template data in the spreadsheet using Microsoft Excel.

3. Use the Oracle InForm User Management Tool user interface to upload theupdated data to Oracle InForm User Management Tool.

• Download the template for a trial

• Update the template for a trial

• Upload the updated data to Oracle InForm User Management Tool

Download the template for a trial1. Select Trials from the menu bar.

2. On the left, above the Trials list, click Download.

The Download Data File dialog appears.

3. In the Trial name drop-down list, select the trial you want to update.

4. In the Excel Template for All Products and Version drop-down list, selectComposite Template.

You are prompted to save or open the template for your selected trial.

Note:

The trial-specific template you download only includes data for user rolesand groups. You can make changes and add additional data for upload.For more information, see Entering data in the MUL Template.

5. Save the template.

Oracle recommends you save the template before editing any data. The file mustbe saved with the .xls extension.

Update the template for a trial1. If it is not already open, open the trial-specific template you downloaded from

Oracle InForm User Management Tool using Microsoft Excel.

Chapter 14Using the MUL Template to add or change data

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Because you selected a download for a specific trial, the Welcome tab is pre-filledwith the appropriate values for your trial.

Note:

To add data and update the template, you must have macros enabled.

2. Click Get Started.

Note:

Depending on how your Excel options are configured, you may see an

Excel error icon ( ) in the Oracle InForm Version field on theWelcome page. You can ignore the icon and associated message, oryou can update your Excel options to remove it. For more information,see Updating your Excel Options.

3. Select the tab for the worksheet containing the data you want to modify.

For example, select the UserRoles tab to create new user roles or mark existinguser roles as applicable or not applicable to the study.

Note:

Many types of trial data including sites and groups can be modified usingthe template. For information on modifying specific types of data usingthe MUL Template, see Entering data in the MUL Template.

4. Enter your data and run any validation or population macros as indicated.

Blue labeled columns indicate required data.

Scroll right to see all available columns as needed.


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The MUL Template can be used to update many types of data. Each worksheetcovers a different data type and has specific steps and caveats you must followwhen making updates. For more information, see Entering data in the MULTemplate..

Depending on the worksheet you select, you may need to run a macro to populateor validate data. This is typically done by clicking a button on the worksheet. Forexample, after you enter data for the desired user roles on the UserRolesworksheet, click the Populate User Roles button to run the applicable macro. Thismacro propagates data to the other worksheets, as needed. For more information,see Entering user roles.


Note:

The template must be saved with an .xls extension. Other extensions arenot valid for upload.

Upload the updated data to Oracle InForm User Management Tool1. Select Trials from the menu bar.

2. On the left, above the Trials list, click Upload.

The Upload Data File dialog box appears.

3. Select a saved template file.

The file must have an .xls extension.

4. In the Filename field, enter the name for your MUL Template, or browse to selectthe template file you want to upload.

5. In the Trial name drop-down list, select the trial name you want to upload data for.

6. In the Import section, select the trial details to import.

7. Click Validate and Import.

Your data is now available in Oracle InForm User Management Tool.

Note:

If there are any failures with the upload, you will receive an email. Logsare available to help you troubleshoot your issues.


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Creating a master template from the MUL TemplateWhile the MUL Template can be used to bulk update data for existing trials, you canalso use it to create a master template that you can use to import common information(such as user roles and rights) into any study. To create a master template, use thefollowing workflow:

1. Use the Oracle InForm User Management Tool user interface to download anempty MUL (composite) Template.

2. Enter any data you want to maintain as part of your master template.

3. Save the spreadsheet for future use and use the Oracle InForm User ManagementTool user interface to upload the data to Oracle InForm User Management Tool forfuture trials.

• Download a blank template

• Add additional study locale languages to the MUL Template

• Update the spreadsheet

Download a blank template1. Select Trials from the menu bar.

2. On the left, above the Trials list, click Download.

The Download Data File dialog appears.

3. Leave the Trial name drop-down as is.

When you leave the trial unspecified, the downloaded template does not includeany pre-filled data.

If you select a trial, the downloaded spreadsheet includes information setaccording to the trial specifics (Oracle InForm version, Oracle IRT use, and SSOenablement) and any roles and rights as specified for that trial.

4. In the Excel Template for All Products and Version drop-down list, selectComposite Template.

You are prompted to save or open the template.


Oracle recommends you save the template before editing any data. The file mustbe saved with the .xls extension.

Add additional study locale languages to the MUL TemplateThe list of values for the Study Locale includes only two values: English (UnitedStates) and Japanese (Japan). If your study design has additional values for the StudyLocale, you can modify the template so that the Study Locale drop-down list displaysthe additional values.

1. Click the Lookups tab.

You may need to unhide this tab by right clicking on a visible tab and thenselecting Unhide, selecting Lookups, and then clicking OK.

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2. In the Study Locale column, add the language you are looking for using theconvention shown on Trial Configurations page when selecting a language.

Note:

The language you select must be configured for that trial (for example,French (France).


Your selection will be available in the Study Locale drop-down list on the SponsorUsers and Site Users tabs.

Update the spreadsheetWhen creating a master template to be used across multiple trials with varying OracleInForm versions and other trial specifics, you can repeat the getting started process,filling in new Welcome values each time. You can repeat this process as many timesas needed (version-specific data is not overridden, simply hidden from view).

1. If it is not already open, open the empty template you downloaded from OracleInForm User Management Tool using Microsoft Excel.

The blank template presents you with a Welcome tab. The information provided onthe Welcome tab is used to make relevant tabs available in the spreadsheet.

Note:

To add data and update the template, you must have macros enabled.

2. Enter the trial specifics on the Welcome tab.

If you are working with multiple versions of InForm or trials that vary with respectto use of SSO or IRT, populating your data is an iterative process.

The information provided on the Welcome tab is used to make relevant tabsavailable in the spreadsheet. Complete the Welcome tab using specifics that mostclosely match a trial you will use this master template for in the future. You canrepeat these steps in the future using different Welcome values.

The Welcome tab requires the following information:

• Sponsor Name—Oracle InForm User Management Tool sponsor name.

• Trial Name—Oracle InForm User Management Tool trial name.

• InForm Version—The Oracle InForm version used with this trial.Depending on how your Excel options are configured, you may see an Excel

error icon ( ) in the Oracle InForm Version field on the Welcome page. Youcan ignore the icon and associated message, or you can update your Exceloptions to remove it. For more information, see Updating your Excel Options.

• SSO?—Indicates whether or not single sign on is enabled for this trial.

• Use IRT?—Indicates whether or not your trial is part of an Oracle IRT study.

Chapter 14Creating a master template from the MUL Template

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Note:

You must enter a Sponsor Name and a Trial Name but these values arenot used in the spreadsheet or during upload. They are for labelingpurposes only. The Oracle InForm version must match the OracleInForm version in Oracle InForm User Management Tool whenuploading for a trial.

3. Click Get Started.

The getting started macro runs. When the macro completes, tabs relevant to yourtrial specifics, such as a version-specific tab for InForm rights and roles, appear.

4. After the getting started process completes, populate the template with data,beginning with the user roles worksheet.

For more information, see Entering user roles.

Note:

Be sure to start with the user roles worksheet. Other worksheets aredependent on this data.

You can populate as much or as little data as you like when creating this mastertemplate. Master templates are commonly used to populate roles and rights thatare common across all studies. However, you may wish to include other commondata such as sponsor users that have access to all studies. For more information,see Entering data in the MUL Template.

5. Save the master template for future use or upload the data for a new trial using theOracle InForm User Management Tool user interface.

Note:

The file must be saved with the .xls extension.

After you have created your master template, you can use the Oracle InForm UserManagement Tool user interface to upload the template for any study by clicking theUpload button and selecting the master template file for upload and selecting whattype of data you want to upload. You can then customize the trial data manually usingthe Oracle InForm User Management Tool user interface or by downloading and usinga trial-specific template as described in Using the MUL Template to add or changedata.

Entering data in the MUL TemplateWhether you use the MUL Template to perform bulk updates of data for an existingtrial or you use it to create a master template, you must update the data tabs asdirected in the template. Some tabs in the MUL Template have dependencies on othertabs. It is important that you fill in the template as directed.

Chapter 14Entering data in the MUL Template

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Note:

You must have macros enabled in the template to properly propagate andvalidate data.

• Adding or updating user roles

• Assigning rights and roles

• Adding groups and assigning a group type

• Assigning reporting groups to roles

• Entering site data

• Entering Sponsor and Site users

• Entering UAT users (Single sign-on trials only)

• Entering signature groups

Adding or updating user rolesYou enter data for user roles on the UserRoles worksheet. You can assign user rolesfor InForm or IRT, depending on your trial details.

Caution:

You must always modify this worksheet first and propagate these changes tothe other worksheets using the Populate User Roles button beforemodifying other worksheets.

New entries and modifications to existing roles are propagated to the relatedSponserUsers and SiteUsers worksheets. Role information is also propagated to theRights&Roles and ReportGroups worksheets.

To add a new role:

1. In a new row, add a name for the role in the User Role column.

2. Optionally, add a description for this role in the Description column.

3. Mark the role as applicable or not applicable to the current study by selectingApplicable or Not Applicable from the drop-down list in the Role requiredcolumn.

4. Click Populate User Roles to propagate the data to the dependent worksheets.

Note:

You may need to enable macros for this to operate correctly.


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To update an existing role:

1. To change the data in the existing rows, perform one of the following:

• Update the role description in the Description column.

• Mark a role as applicable or not applicable to the study by selecting thedesired value (Applicable or Not Applicable) from the drop-down list incolumn C.

– Marking a role as Applicable adds information for that role to theSponserUsers, SiteUsers, and ReportGroups worksheets.

– Marking a role as Not Applicable removes information from theSponserUsers, SiteUsers, Rights&Roles, and ReportGroupsworksheets.

2. Click Populate User Roles to propagate the data to the dependent worksheets.

Assigning rights and rolesRights and roles are assigned on a product- and version-specific Rights&Rolesworksheet (for example, the worksheet for updating the rights and roles associatedwith Oracle InForm 6.2 is labeled InForm 6.2 Rights&Roles).

Note:

User role information included on these worksheets is propagated from theUserRoles worksheet. You must complete the UserRoles worksheet andpropagate your changes before updating any Rights&Roles worksheet. Formore information, see Entering user roles.

• To assign or update the role type or rights for a given user role, type an X in thecell that corresponds to the role type or right you want to apply.

Adding groups and assigning a group typeYou add groups and assign them a group type in the Groups worksheet. Group dataentered in this worksheet is populated to the SiteUsers and SponsorUsersworksheets.

You can update data for existing groups by selecting a new Type or editing theDescription.

Note:

Do not change the Group Name for a group if you have already uploadedgroup data to a trial in Oracle InForm User Management Tool, or if you havedownloaded a trial-specific template from Oracle InForm User ManagementTool.

To add a new group:

1. Enter a name for the group in the Group Name column.


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2. Select a group type from the available list using the drop-down list in the Typecolumn.

You can select either Signature Group or Query Group.

3. Optionally, add a description for the group in the Description column.

4. Click Populate Groups to propagate group data to the dependent worksheets.

Note:

The Groups worksheet is only for assigning signature and query groups.

Item groups and display overrides are defined in Oracle Central Designer forOracle InForm 6.1 and above, and in the Oracle InForm User ManagementTool user interface for earlier versions.

For signature groups, the content of the group is defined in Oracle CentralDesigner for Oracle InForm 6.0 and above, and in the Oracle InForm UserManagement Tool user interface for earlier versions.

Assigning reporting groups to rolesUse the ReportGroups worksheet to assign your user roles (as defined in theUserRoles worksheet) to specific report groups. The report groups provide access toCognos Reporting and are pre-defined.

Note:

Do not change the Report Groups column on this worksheet and do not addnew rows.

If you have properly propagated your role information, you see a column for each roleon this worksheet. If you don’t see columns for your roles, see Entering user roles.

• To assign a role to a reporting group, type an X in the cell corresponding to thereporting group you want your role to be assigned to.

Entering site dataYou enter data for sites on the Sites worksheet. You can add new sites, change datafor existing sites, delete existing sites, or re-instate a site.

Blue-labeled columns are required fields and data must be filled in according to theformats specified in the spreadsheet. For example, when entering phone numbers onlyinclude digits and start the number with the appropriate country code.

• Do not leave blank rows between entries.This prevents the data from being properly validated.

• For site names only, you can use alpha numeric characters or apostrophe ( ' ),comma ( , ), dash ( - ), period ( . ), semi-colon ( ; ), colon ( : ), or underscore ( _ )characters.


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The apostrophe ( ' ) character can only be used in Oracle InForm 6.2 and above.No foreign accents or special characters are allowed. Do not use carriage returnsin addresses.

• For Oracle IRT trials only, leaving the Limit ship address field to 30 checkboxunchecked allows you to provide a shipping address up to 255 characters.

• You must select a time zone in the Time Zone column.However, the time zone-related data in the Time Zones 2011/Time Zones Dec2012 conversion time column is populated for you based on the time zone youselect.

• The optional Date Format column allows the trial’s default date format to beoverridden on a site-by-site basis.This is configured in the Oracle InForm User Management Tool configuration for atrial. If you are using a trial configuration document and this is left blank, the dateformat provided in the trial configuration document is used.

• The mandatory Accept Date column should be populated with the date that thesite was added to the MUL template.

• If the Oracle InForm User Management Tool configuration for the trial is set toMULTIPLE and you are re-instating a site, the Study Version column ismandatory (this value is checked as part of the upload to Oracle InForm UserManagement Tool).

– If your trial is configured for MULTIPLE and you create a new site, you caneither specify a study version in this column or the version will default to theearliest study version entered in Oracle InForm User Management Tool.

– If your trial is configured for LATEST, a study version is not required.

Note:

When specifying a trial version, you must enter it exactly as it appears inOracle Central Designer.

• Updating site data

Updating site dataTo update site data using the Sites worksheet:

1. Update the site data.

Keep in mind the requirements listed in Entering site data, any formattinginformation provided in the spreadsheet, and any optional information that mightbe required due to your trial configuration.

If you want to change a site mnemonic using the MUL Template or .DAT file, see Changing a site mnemonic.

2. Set the status for each site.

Choose one of the following selections from the drop-down list in the Statuscolumn:

• New—Creates a new site entry in Oracle InForm User Management Tool.


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• No Change—Identifies a site already created and uploaded in Oracle InFormUser Management Tool.

– If you leave the status as New instead of changing it to No Change afterthe site has been created in Oracle InForm User Management Tool, theimport will fail for the site.

– After a site is successfully uploaded as New, if you want to leave the sitein the template for the next load, you must change the status to NoChange unless you are changing, deleting (marking as not participating),or re-instating (marking as participating) the site.

• Change—Change the data for an existing site in Oracle InForm UserManagement Tool.

• Delete—Mark a site as Not Participating in Oracle InForm User ManagementTool.

• Re-instate—Return the site to Participating status in Oracle InForm UserManagement Tool. Sponsor users that have auto-association set to beassigned to the site get assigned.

3. Click Validate.

If an error is encountered during validation, the required field will be highlighted.Review the error message provided in the Error Message column for moreinformation (you may need to scroll right to see the column).

Entering Sponsor and Site usersUse the SponsorUsers worksheet and the SiteUsers worksheet to enter or changeinformation for users at the sponsor level and site level, respectively. The instructionsare the same regardless of which type of user you are entering.

Blue-labeled columns are required fields and data must be filled in according to theformats specified in the spreadsheet. For example, when entering phone numbers onlyinclude digits and start the number with the appropriate country code.

• Role columns are populated from the UserRoles worksheet.You must complete the UserRoles worksheet and populate the data before youenter user information. For more information, see Entering user roles.

• The signature group and query group drop-downs are populated from theinformation you provide on the Groups tab.If you want to assign users to signature or query groups, be sure you have createdand populated these groups. For more information, see Entering groups.

• The username entered in the User Name field must not have spaces and must bein lowercase.The maximum length is 63 characters for Oracle InForm 6.0 and above (olderversions have a 32 character limit).

Usernames must be unique.

Oracle recommends you use the user’s email address as their username. If this isnot permitted due to the character limitation, use the first initial of the user’s firstname plus their last name. For example, jdoe for the user John Doe.


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Note:

For SSO-enabled trials, usernames must be at least 4 characters.

• The Display Name column sets the name that appears in the left corner of OracleInForm under the user photo.

• When you upload a new user for an SSO study, Oracle InForm User ManagementTool checks to see if the user is already a Global User by matching the user nameand email address against existing Global Users.

– If the user exists, Oracle InForm User Management Tool associates the newstudy user to the existing Global User.

– If the user does not exist in the Global User list, it is automatically created.

The new user appears in the user interface in both the Study Users list and theGlobal Users list.

• Updating Sponsor and Site users

Updating Sponsor and Site usersYou can update users using the SiteUsers or SponsorUsers worksheet.

1. Update the site user or sponsor user data.

Be sure you are adding the user data to the correct worksheet for that user type,site or sponsor.

For UAT users, see Entering UAT users (Single sign-on trials only)

Keep in mind the requirements listed in Entering site data, and follow anyformatting information provided in the spreadsheet.

2. Set the status for each user.

Choose one of the following selections from the drop-down list in the Statuscolumn:

• New—Creates a new user entry in Oracle InForm User Management Tool.

• No Change—Identifies a user already created and uploaded in Oracle InFormUser Management Tool.

– If you leave the status as New instead of changing it to No Change afterthe user has been created in Oracle InForm User Management Tool, theimport will fail for the user.

– After a user is successfully uploaded as New, if you want to leave the userin the template for the next load, you must change the status to NoChange unless you are changing, deleting (terminating), or re-instating(unterminating) the user.

• Change—Change the data for an existing user in Oracle InForm UserManagement Tool.

• Delete—Mark a user as Terminated in Oracle InForm User ManagementTool.

• Re-instate—Un-terminate (re-instate) the user in Oracle InForm UserManagement Tool.


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3. Click Validate.

If an error is encountered during validation, the required field will be highlighted.Review the error message provided in the Error Message column for moreinformation (you may need to scroll right to see the column).

Entering UAT users (Single sign-on trials only)If you are entering data for a Single Sign-On (SSO) trial, you must create your users inOracle InForm User Management Tool. Because an Oracle InForm user can only haveone role, you must have multiple user accounts, one for each role that you need totest. The UAT users tab helps you create these users.

To create UAT users:

1. Update the user data.

Blue-labeled columns indicate required data. Data must be filled in according tothe formats specified in the spreadsheet. For example, when entering phonenumbers only include digits and start the number with the appropriate countrycode. The values for some fields, such as Product Locale, are selected from adrop-down list.

2. Select the applicable roles that you need the UAT user accounts created for.

Select the applicable roles by typing an X in the column that corresponds to therequired role.

Note:

Role columns are populated from the UserRoles worksheet. You mustcomplete the UserRoles worksheet and populate the data before youenter user information. For more information, see Entering user roles.You must also enter the role type on the Rights&Roles worksheet andpropagate that data as well. For more information, see Entering rightsand roles.

3. Click Create UAT Users.

For each role that is a site type role, the macro creates a user on the SiteUsers tabas username_uat_role. Similarly, for each role that is a sponsor type, the macrocreates a user on the SponsorUsers tab with the same format.

Entering signature groupsThe Signature worksheet is not used with Oracle InForm versions 6.1 and above. Ifyou are working with a release prior to 6.1, you can unhide this tab by right-clicking onany worksheet tab and selecting Unhide > Signature. In Oracle InForm 6.1 andabove, signature groups are defined in Oracle Central Designer.

Data must be filled for all columns.

1. Before you begin entering data, click the Populate Signature Group button topopulate the list of signature group type group names in the Signature Groupcolumn.

Values can be chosen from this list.


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2. In the Final CRF column for the form, choose Casebook Signature or CRFSignature.


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15Managing SSO accounts—Oracle HealthIAMS Customer Delegated Administrator(CDA)

• Resetting a user SSO password

• Locking a user SSO account

• Unlocking a user SSO account

Resetting a user SSO passwordTo manually reset the password for a user account:

1. Access Oracle Health Sciences Identity and Access Management Service(Oracle Health IAMS) using the link in the email you received with the temporarypassword from [email protected] when your CDA accountwas created.

2. Navigate to the User Details page.

a. Under Administration in the menu on the left, click Users.

b. For the Display Name:

• From the list, select Equals.

• Type the user name in the field.

c. Click Search on the right.

d. In the Search Results section, click the link in the User Login column to openthe User Details page.

3. In the row of controls at the top of the page, click Reset Password.

4. Perform one of the following depending on the password reset flow you have set:

• If the user is not required to use challenge questions, click Send on theConfirmation screen.

• If the user is required to use challenge questions, select Auto-generate thePassword.

Note:

Although it is not recommended, you can manually define a newpassword: Select Manually change the Password, fill in the passwordfields, and select the checkbox E-mail the new password to the user.

5. Click Reset Password.

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Locking a user SSO accountWhen a delegated administrator explicitly locks an account, the user cannot use theForgot Password link to regain access. Lock a user account to prevent the user fromlogging in before you disable the account for termination of employment or for otherreasons.









3. In the row of controls at the top of the page, click Lock Account.

4. In the confirmation dialog, click Lock.

Unlocking a user SSO accountIf the account was explicitly locked by a delegated administrator, you need to unlockthe account before it can be used again. Users who lock their accounts by entering anincorrect password too many times can use the Forgot Password link on the loginpage to reset their passwords and unlock their account.

Before unlocking an account, check the reason for which it was locked in the first placeand check that the person asking to have the account unlocked is the owner. Toensure system security, we recommend that you establish a process to confirm therequester's identity.









Chapter 15Locking a user SSO account

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3. In the row of controls at the top of the page, click Unlock Account.

4. In the confirmation dialog, click Unlock.

5. Reset the password.

For more information, see Resetting a user SSO password.

Chapter 15Unlocking a user SSO account

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